An interventional study of EDWARDS INTUITY Valve System, Model 8300A and Stented Aortic Bioprostheses in Aortic Valve Disease and Aortic Stenosis, sponsored by Edwards Lifesciences. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore \< 20 undergoing elective isolated aortic valve replacement (AVR) surgery.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.
234 studies on the registry are indexed under Aortic Valve Disease; 75 are open to participants now.
This study's enrollment of 100 is close to the median of 107 across 119 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Edwards Lifesciences is the lead sponsor of 128 studies on the registry; 18 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 33 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion (i.a.):
requires emergency surgery or has had emergency surgery for any reason
≤ 1 month before the intended treatment
Intra-operative Exclusion:
EDWARDS INTUITY Valve System, Model 8300A
Device: EDWARDS INTUITY Valve System, Model 8300A
Stented Aortic Bioprostheses
Device: Stented Aortic Bioprostheses
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.
Also known as: aortic stenosis, stenosis-based insufficiency, aortic valve replacement
In comparison to control valves available on the market undergoing FS-AVR
Also known as: aortic stenosis, stenosis-based insufficiency, aortic valve replacement
Median Subject Time Spent on Cardiopulmonary Cross Clamp
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Time frame: At time of surgery; an average of 1 hour
Median Amount of Time Subject Spent on Cardiopulmonary Bypass
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Time frame: At time of surgery; an average of 1 hour
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Time frame: Baseline and 2 Years.
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year
Subject's Effective Orifice Area (EOA) Measurement Over Time.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year
Amount of Paravalvular Leak Over Time.
Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: Discharge, 30 days, 3 month, 1 year
Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Time frame: Prior to Surgery
Subjects Who Required a Thoracic Resternotomy Over Time
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects Who Received a Permanent Pacemaker Over Time.
Number of Subjects who received a Permanent Pacemaker shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time
Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects Who Experienced Major Bleeding Over Time.
Number of subjects who experienced Major Bleeding shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects Who Experienced Respiratory Failure Over Time
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With Renal Failure Over Time
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With Endocarditis Over Time
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Deep Sternal Would Infection Over Time
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Myocardial Infarction Over Time
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Thromboembolism Over Time
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Cardiac Tamponade Over Time
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Subjects With a Cardiac Reoperation for Any Reason Over Time
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Time frame: 30 days, 3 Months, 1 Year, 2 Years.
Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.
Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.
Time frame: Prior to Surgery
Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time frame: Baseline, 30 days, 3 Months, 1 Year
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Time frame: Baseline, 30 days, 3 Months, 1 Year
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.
Time frame: Baseline, 30 days, 3 Months, 1 Year
Health Care Utilization
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Time frame: Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time frame: Baseline, Discharge, 30 days, 3 Months, 1 Year
Amount of Aortic Valvular Regurgitation Over Time.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.
Time frame: Discharge, 30 days, 3 month, 1 year
All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start.
| Milestone | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Started | 51 | 49 |
| Intent to treated (itt) randomized arm | 49 | 48 |
| As treated (at) randomized arm/group | 46 | 51 |
| As intended (ai) randomized arm/group | 46 | 48 |
| Completed | 39 | 41 |
| Not completed | 12 | 8 |
| Withdrew: Death | 3 | 5 |
| Withdrew: Valve explant | 1 | 0 |
| Withdrew: Conversion to commercial valve | 3 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Intraoperative screen failure | 2 | 0 |
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
| Minutes | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Median Subject Time Spent on Cardiopulmonary Cross Clamp | 35.0 (16.0 to 115.0) | 47.5 (32.0 to 123.0) |
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
| Minutes | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Median Amount of Time Subject Spent on Cardiopulmonary Bypass | 58.5 (38.0 to 161.0) | 69.0 (39.0 to 170.0) |
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Improved | 22 | 27 |
| Same | 17 | 11 |
| Worsened | 1 | 1 |
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
| mmHg | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Baseline | 44.0 ± 15.9 | 45.4 ± 20.0 |
| Discharge | 10.3 ± 5.4 | 10.8 ± 3.4 |
| 30 days | 8.8 ± 4.2 | 9.7 ± 3.9 |
| 3 months | 9.1 ± 4.2 | 10.3 ± 4.8 |
| 1 year | 9.1 ± 2.9 | 11.5 ± 4.3 |
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
| mmHg | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Baseline | 69.6 ± 23.7 | 75.4 ± 27.9 |
| Discharge | 19.0 ± 9.5 | 21.0 ± 6.9 |
| 30 days | 16.5 ± 7.8 | 17.8 ± 6.5 |
| 3 months | 17.0 ± 7.6 | 18.9 ± 8.2 |
| 1 year | 16.9 ± 5.3 | 21.9 ± 8.6 |
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
| centimeters squared | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Baseline | 0.7 ± 0.2 | 0.7 ± 0.2 |
| Discharge | 1.9 ± 0.6 | 1.9 ± 0.7 |
| 30 days | 1.9 ± 0.5 | 2.0 ± 0.7 |
| 3 months | 1.9 ± 0.5 | 1.8 ± 0.6 |
| 1 year | 1.9 ± 0.5 | 1.7 ± 0.4 |
Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Discharge — 0 None | 30 | 33 |
| Discharge — +1 Trivial/Trace | 10 | 7 |
| Discharge — +2 Mild | 1 | 3 |
| Discharge — +3 Moderate | 0 | 0 |
| Discharge — +4 Severe | 0 | 0 |
| 30 days — 0 None | 27 | 24 |
| 30 days — +1 Trivial/Trace | 6 | 11 |
| 30 days — +2 Mild | 1 | 1 |
| 30 days — +3 Moderate | 0 | 0 |
| 30 days — +4 Severe | 0 | 0 |
| 3 months — 0 None | 26 | 27 |
| 3 months — +1 Trivial/Trace | 13 | 9 |
| 3 months — +2 Mild | 2 | 3 |
| 3 months — +3 Moderate | 1 | 0 |
| 3 months — +4 Severe | 0 | 0 |
| 1 year — 0 None | 23 | 34 |
| 1 year — +1 Trivial/Trace | 9 | 6 |
| 1 year — +2 Mild | 3 | 0 |
| 1 year — +3 Moderate | 1 | 0 |
| 1 year — +4 Severe | 0 | 0 |
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery. | 3 | 0 |
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 6 | 5 |
| 3 months | 6 | 5 |
| 1 year | 7 | 5 |
| 2 year | 7 | 5 |
Number of Subjects who received a Permanent Pacemaker shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 2 | 1 |
| 3 months | 2 | 1 |
| 1 year | 2 | 1 |
| 2 year | 3 | 2 |
Number of subjects who experienced a Paravalvular Leak shown over various time points. Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 0 | 1 |
| 3 months | 0 | 1 |
| 1 year | 2 | 1 |
| 2 year | 2 | 1 |
Number of subjects who experienced Major Bleeding shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 8 | 4 |
| 3 months | 8 | 5 |
| 1 year | 8 | 5 |
| 2 year | 8 | 5 |
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 2 | 0 |
| 3 months | 2 | 0 |
| 1 year | 2 | 2 |
| 2 year | 2 | 2 |
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 2 | 2 |
| 3 months | 2 | 2 |
| 1 year | 2 | 2 |
| 2 year | 3 | 2 |
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 3 | 0 |
| 3 months | 3 | 0 |
| 1 year | 3 | 1 |
| 2 year | 3 | 1 |
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 0 | 0 |
| 3 months | 0 | 0 |
| 1 year | 0 | 0 |
| 2 year | 0 | 0 |
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 1 | 1 |
| 3 months | 1 | 1 |
| 1 year | 1 | 1 |
| 2 year | 1 | 1 |
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 0 | 1 |
| 3 months | 0 | 1 |
| 1 year | 0 | 2 |
| 2 year | 0 | 2 |
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 3 | 3 |
| 3 months | 3 | 3 |
| 1 year | 4 | 4 |
| 2 year | 5 | 4 |
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 2 | 3 |
| 3 months | 2 | 3 |
| 1 year | 2 | 3 |
| 2 year | 2 | 3 |
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| 30 days | 6 | 5 |
| 3 months | 6 | 5 |
| 1 year | 7 | 6 |
| 2 year | 7 | 6 |
Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery. | 0 | 0 |
The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
| units on a scale | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Baseline | 0.900 ± 0.097 | 0.902 ± 0.087 |
| 30 day | 0.862 ± 0.080 | 0.902 ± 0.094 |
| 3 month | 0.908 ± 0.080 | 0.918 ± 0.077 |
| 1 year | 0.922 ± 0.086 | 0.925 ± 0.086 |
Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12. The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS). The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
| units on a scale | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| PCS - Baseline | 42.39 ± 9.18 | 40.79 ± 9.96 |
| PCS - 30 day | 36.16 ± 10.08 | 38.45 ± 7.86 |
| PCS - 3 month | 41.42 ± 8.19 | 43.95 ± 7.88 |
| PCS - 1 year | 43.84 ± 9.46 | 44.70 ± 8.39 |
| MCS - Baseline | 48.02 ± 12.85 | 50.07 ± 11.80 |
| MCS - 30 day | 48.06 ± 12.88 | 50.26 ± 11.78 |
| MCS - 3 month | 49.87 ± 11.28 | 51.37 ± 9.76 |
| MCS - 1 year | 51.08 ± 8.80 | 52.46 ± 8.58 |
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.
| units on a scale | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Baseline | 58.37 ± 24.79 | 61.33 ± 24.20 |
| 30 day | 57.81 ± 23.64 | 64.33 ± 24.90 |
| 3 month | 69.32 ± 23.58 | 76.35 ± 19.91 |
| 1 year | 73.85 ± 21.25 | 78.11 ± 21.05 |
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
| Days | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Length of stay | 10.9 ± 7.0 | 11.5 ± 9.2 |
| ICU Length of stay | 2.6 ± 5.4 | 1.6 ± 1.5 |
| Intermediate Care Length of stay | 1.3 ± 1.7 | 0.9 ± 1.3 |
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
| centimeters squared/meters squared | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Baseline | 0.4 ± 0.1 | 0.4 ± 0.1 |
| Discharge | 0.9 ± 0.3 | 1.0 ± 0.4 |
| 30 days | 1.0 ± 0.3 | 1.1 ± 0.3 |
| 3 months | 1.0 ± 0.2 | 1.0 ± 0.3 |
| 1 year | 1.0 ± 0.3 | 0.9 ± 0.2 |
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.
| Participants | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| Discharge — 0 None | 29 | 29 |
| Discharge — +1 Trivial/Trace | 10 | 13 |
| Discharge — +2 Mild | 1 | 2 |
| Discharge — +3 Moderate | 0 | 0 |
| Discharge — +4 Severe | 0 | 0 |
| 30 days — 0 None | 25 | 29 |
| 30 days — +1 Trivial/Trace | 10 | 6 |
| 30 days — +2 Mild | 0 | 3 |
| 30 days — +3 Moderate | 0 | 0 |
| 30 days — +4 Severe | 0 | 0 |
| 3 months — 0 None | 27 | 25 |
| 3 months — +1 Trivial/Trace | 13 | 13 |
| 3 months — +2 Mild | 2 | 2 |
| 3 months — +3 Moderate | 1 | 0 |
| 3 months — +4 Severe | 0 | 0 |
| 1 year — 0 None | 25 | 28 |
| 1 year — +1 Trivial/Trace | 10 | 11 |
| 1 year — +2 Mild | 5 | 1 |
| 1 year — +3 Moderate | 0 | 0 |
| 1 year — +4 Severe | 0 | 0 |
Collected over Events occurring from baseline through two (2) years post implant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Edwards INTUITY Surgical Aortic Heart Valve | 4/49 (8.2%) | 31/49 (63.3%) | 27/49 (55.1%) |
| Control Group - Commercial Surgical Aortic Heart Valve | 4/48 (8.3%) | 27/48 (56.3%) | 30/48 (62.5%) |
| Event | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| MUSCULAR SKELETAL / DERMATOLOGIC - OTHERMusculoskeletal and connective tissue disorders | 2/49 | 6/48 |
| PLEURAL EFFUSION - BILATERALRespiratory, thoracic and mediastinal disorders | 5/49 | 3/48 |
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)Cardiac disorders | 4/49 | 4/48 |
| BLEEDING - CARDIOVASCULAR - MAJORBlood and lymphatic system disorders | 4/49 | 1/48 |
| PERICARDIAL TAMPONADE - MAJORCardiac disorders | 2/49 | 3/48 |
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATIONGeneral disorders | 2/49 | 3/48 |
| PERICARDIAL EFFUSION - MAJORCardiac disorders | 3/49 | 0/48 |
| GASTROINTESTINAL - OTHERGastrointestinal disorders | 3/49 | 2/48 |
| GENITOURINARY - OTHERRenal and urinary disorders | 3/49 | 0/48 |
| RESPIRATORY INFECTION - PNEUMONIARespiratory, thoracic and mediastinal disorders | 3/49 | 2/48 |
| Event | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve |
|---|---|---|
| ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)Cardiac disorders | 4/49 | 6/48 |
| PERICARDIAL EFFUSION - MINORCardiac disorders | 3/49 | 5/48 |
| MUSCULAR SKELETAL / DERMATOLOGIC - OTHERMusculoskeletal and connective tissue disorders | 5/49 | 5/48 |
| ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATIONCardiac disorders | 0/49 | 3/48 |
| GASTROINTESTINAL - OTHERGastrointestinal disorders | 1/49 | 3/48 |
| PLEURAL EFFUSION - BILATERALRespiratory, thoracic and mediastinal disorders | 2/49 | 3/48 |
| ANEMIA - NON-BLEEDING RELATEDBlood and lymphatic system disorders | 1/49 | 2/48 |
| RENAL FAILURE - ACUTERenal and urinary disorders | 1/49 | 2/48 |
| NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATIONGeneral disorders | 1/49 | 2/48 |
| TRANSIENT PSYCHOTIC SYNDROMEPsychiatric disorders | 2/49 | 2/48 |
3 of the subjs. randomized to the Edwards INTUITY group were converted to the control group and rec'd commercially available surgical aortic heart valves.From the overall,2 randomized to Edwards INTUITY \&1 randomized to control group were screen failures prior to procedure \& were excluded in the baseline analysis.Analysis is based on the AI cohort
| Age, Continuous(Years) | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | Total |
|---|---|---|---|
| Mean | 73.0 ± 5.3 | 74.2 ± 5.0 | 73.61 ± 5.17 |
| Sex: Female, Male(Participants) | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | Total |
|---|---|---|---|
| Female | 19 | 27 | 46 |
| Male | 27 | 21 | 48 |
| Region of Enrollment(Participants) | Edwards INTUITY Surgical Aortic Heart Valve | Control Group - Commercial Surgical Aortic Heart Valve | Total |
|---|---|---|---|
| Europe | 46 | 48 | 94 |
Plan to share: No — As of this date no IPD plan has been formulated.
The record gives a start of May 2012, a primary completion of Mar 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 3 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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