CompletedNCT01445171TRITONUpdated Sep 1, 2023Results posted

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

An interventional study of Aortic Valve Replacement with EDWARDS INTUITY Valve System in Aortic Valve Stenosis With Insufficiency and Aortic Valve Stenosis, sponsored by Edwards Lifesciences. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 295
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Read the detailed description

This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Conditions studied

Aortic Valve Stenosis With Insufficiency
Aortic Valve Stenosis

Browse trials for

Aortic Valve Stenosis 1,006

Keywords

Aortic Valve Replacement

In context

Aortic Valve Stenosis

1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

This study's enrollment of 295 is above the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

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.

Browse Edwards Lifesciences studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

Criteria:

Inclusion criteria

Inclusion Criteria:

18 years or older
Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
Signed and dated the informed consent form prior to investigation procedures;
Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.

Exclusion criteria

Exclusion Criteria:

Pure aortic insufficiency
Requires emergency surgery
Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
Left ventricular ejection fraction of ≤ 25%
Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery
Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis
Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring.
Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery
Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
Disease limiting life expectancy to less than 12 months
Pregnant or lactating
Currently participating in another drug or device clinical investigation;
Documented blood diatheses
Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal
Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery
Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
Documented hyperparathyroidism

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 295 participants (actual)

Study arms

Other
Study Valve
Subjects act as own control
Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

Interventions

DeviceAortic Valve Replacement with EDWARDS INTUITY Valve System
Aortic Valve bioprosthesis

What researchers measure

Primary outcomes

Percent of Early Adverse Events
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Time frame: Events occuring within 30 days of procedure
Percent of Late Adverse Events
Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time frame: Events occurring >= 31 days and up through 5 years post-implant

Other outcomes

Number of Subject's With Device Technical Success
Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.
Time frame: At time of surgery, an average of 3 hours
Number of Subject's With Procedural Success
Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.
Time frame: Discharge(an average of 13 days) or 10 days post-implant, whichever comes first
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
The 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, 3 Months, and 1 Year post-implant
Subject's Average Mean Systolic Gradient 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: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average Effective Orifice Area Measurements 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: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's 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.
Time frame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average White Blood Cell Count Measurement Over Time.
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Red Blood Cells Count Over Time.
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Hemoglobin Count Over Time.
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Hematocrit Percentage Over Time.
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Platelet Count Over Time.
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Reticulocytes Percentage Over Time.
Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Haptoglobin Measurement Over Time.
Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Subject's Average Serum LDH Measurement Over Time.
The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Time frame: Baseline, 3 Months, 1 Year, and 5 Years post-implant

Results

Posted Feb 17, 2020

Participant flow

Participant flow — Overall Study
Milestone	INTUITY Aortic Valve and INTUITY Delivery System
Started	295
Implanted with study device	287
Completed	200
Not completed	95
Withdrew: Lost to follow-up	11
Withdrew: Withdrawal by subject	16
Withdrew: Death	51
Withdrew: Subjects declined to return for followup	9
Withdrew: Consented but did not receive device	8

Outcome measures

PrimaryPercent of Early Adverse Events

Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.

Time frame:: Events occuring within 30 days of procedure
Reported as:: Number · Percentage of subjects

Percent of Early Adverse Events
Percentage of subjects	INTUITY Aortic Valve and INTUITY Delivery System
All Cause Mortality	1.7
Trial Valve Related Mortality	1.0
Thromboembolism	4.5
Valve Thrombosis	0.0
Major Bleeding	7.3
All Paravalvular Leak (OPC)	1.0
Hemolysis	0.7
Endocarditis	0.0
Structural Valve Deterioration	0.0
Reoperation	1.4
Explant	1.4
Valve Related AE	3.1

PrimaryPercent of Late Adverse Events

Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Time frame:: Events occurring >= 31 days and up through 5 years post-implant
Reported as:: Number · Percentage of late adverse events

Percent of Late Adverse Events
Percentage of late adverse events	INTUITY Aortic Valve and INTUITY Delivery System
All Cause Mortality	3.8
Trial Valve Related Mortality	0.4
Thromboembolism	1.9
Valve Thrombosis	0.0
Major Bleeding	2.1
All Paravalvular Leak (OPC)	0.6
Hemolysis	0.2
Endocarditis	0.3
Structural Valve Deterioration	0.5
Reoperation	0.5
Explant	0.5
Valve Related AE	1.0

Other pre-specifiedNumber of Subject's With Device Technical Success

Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.

Time frame:: At time of surgery, an average of 3 hours
Reported as:: Count of participants · Participants

Number of Subject's With Device Technical Success
Participants	INTUITY Aortic Valve and INTUITY Delivery System
Number of Subject's With Device Technical Success	287

Other pre-specifiedNumber of Subject's With Procedural Success

Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.

Time frame:: Discharge(an average of 13 days) or 10 days post-implant, whichever comes first
Reported as:: Count of participants · Participants

Number of Subject's With Procedural Success
Participants	INTUITY Aortic Valve and INTUITY Delivery System
Number of Subject's With Procedural Success	277

Other pre-specifiedSubject's New York Heart Association (NYHA) Functional Class Compared to Baseline

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Time frame:: 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Reported as:: Count of participants · Participants

Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
Participants	INTUITY Aortic Valve and INTUITY Delivery System
1 Month — Improved	121
1 Month — Same	59
1 Month — Worsened	14
3 Months — Improved	189
3 Months — Same	65
3 Months — Worsened	8
1 Year — Improved	191
1 Year — Same	57
1 Year — Worsened	7
2 Years — Improved	180
2 Years — Same	46
2 Years — Worsened	12
3 Years — Improved	157
3 Years — Same	56
3 Years — Worsened	12
4 Years — Improved	137
4 Years — Same	60
4 Years — Worsened	10
5 Years — Improved	125
5 Years — Same	52
5 Years — Worsened	16

Other pre-specifiedSubject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time

The 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, 3 Months, and 1 Year post-implant
Reported as:: Mean · units on a scale

Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
units on a scale	Baseline and 3 Months Follow-Up	Baseline and 1 Year Follow-Up
Baseline	0.79 ± 0.20	0.79 ± 0.19
Follow-Up	0.87 ± 0.18	0.83 ± 0.22

Other pre-specifiedSubject's Average Mean Systolic Gradient 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:: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Reported as:: Mean · mmHg

Subject's Average Mean Systolic Gradient Measurements Over Time.
mmHg	INTUITY Aortic Valve and INTUITY Delivery System
Discharge	10.6 ± 4.2
1 Month	9.5 ± 2.8
3 Months	9.0 ± 3.4
1 Year	9.0 ± 3.5
2 Years	8.8 ± 3.0
3 Years	9.6 ± 4.3
4 Years	10.0 ± 4.7
5 Years	9.9 ± 5.1

Other pre-specifiedSubject's Average Effective Orifice Area Measurements 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:: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Reported as:: Mean · Centimeters Squared

Subject's Average Effective Orifice Area Measurements Over Time.
Centimeters Squared	INTUITY Aortic Valve and INTUITY Delivery System
Discharge	1.7 ± 0.2
1 Month	1.6 ± 0.2
3 Months	1.7 ± 0.2
1 Year	1.7 ± 0.2
2 Years	1.7 ± 0.2
3 Years	1.7 ± 0.2
4 Years	1.7 ± 0.3
5 Years	1.7 ± 0.3

Other pre-specifiedSubject's 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.

Time frame:: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Reported as:: Count of participants · Participants

Subject's Amount of Aortic Valvular Regurgitation Over Time
Participants	INTUITY Aortic Valve and INTUITY Delivery System
Discharge — 0 None/+1 Trivial	244
Discharge — +2 Mild	10
Discharge — +3 Moderate	2
Discharge — +4 Severe	1
1 Month — 0 None/+1 Trivial	10
1 Month — +2 Mild	1
1 Month — +3 Moderate	0
1 Month — +4 Severe	0
3 Months — 0 None/+1 Trivial	235
3 Months — +2 Mild	11
3 Months — +3 Moderate	4
3 Months — +4 Severe	1
1 Year — 0 None/+1 Trivial	231
1 Year — +2 Mild	14
1 Year — +3 Moderate	3
1 Year — +4 Severe	0
2 Years — 0 None/+1 Trivial	86
2 Years — +2 Mild	7
2 Years — +3 Moderate	4
2 Years — +4 Severe	0
3 Years — 0 None/+1 Trivial	177
3 Years — +2 Mild	12
3 Years — +3 Moderate	4
3 Years — +4 Severe	0
4 Years — 0 None/+1 Trivial	125
4 Years — +2 Mild	11
4 Years — +3 Moderate	4
4 Years — +4 Severe	0
5 Years — 0 None/+1 Trivial	161
5 Years — +2 Mild	9
5 Years — +3 Moderate	4
5 Years — +4 Severe	0

Other pre-specifiedSubject's Average White Blood Cell Count Measurement Over Time.

Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · 10^3 cells/microliters

Subject's Average White Blood Cell Count Measurement Over Time.
10^3 cells/microliters	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	6.80 ± 2.0
3 Months	6.97 ± 1.8
1 Year	7.10 ± 2.0
5 Years	7.31 ± 2.0

Other pre-specifiedSubject's Average Red Blood Cells Count Over Time.

Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · 10^6 cells/microliters

Subject's Average Red Blood Cells Count Over Time.
10^6 cells/microliters	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	4.30 ± 0.5
3 Months	4.40 ± 0.5
1 Year	4.36 ± 0.5
5 Years	4.35 ± 0.8

Other pre-specifiedSubject's Average Hemoglobin Count Over Time.

Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · g/dl

Subject's Average Hemoglobin Count Over Time.
g/dl	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	12.87 ± 1.7
3 Months	12.49 ± 1.4
1 Year	13.00 ± 1.5
5 Years	13.16 ± 1.6

Other pre-specifiedSubject's Average Hematocrit Percentage Over Time.

Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · percentage of red blood cells

Subject's Average Hematocrit Percentage Over Time.
percentage of red blood cells	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	38.29 ± 4.7
3 Months	38.07 ± 4.1
1 Year	38.93 ± 4.1
5 Years	39.58 ± 4.4

Other pre-specifiedSubject's Average Platelet Count Over Time.

Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · 10^3 platelets per microliter

Subject's Average Platelet Count Over Time.
10^3 platelets per microliter	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	220.33 ± 66.30
3 Months	223.07 ± 59.70
1 Year	213.22 ± 60.40
5 Years	206.85 ± 63.5

Other pre-specifiedSubject's Average Reticulocytes Percentage Over Time.

Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · percentage of reticulocytes

Subject's Average Reticulocytes Percentage Over Time.
percentage of reticulocytes	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	2.13 ± 2.5
3 Months	1.59 ± 1.9
1 Year	2.07 ± 5.0
5 Years	1.82 ± 2.2

Other pre-specifiedSubject's Average Haptoglobin Measurement Over Time.

Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · g/L

Subject's Average Haptoglobin Measurement Over Time.
g/L	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	63.08 ± 69.50
3 Months	82.15 ± 81.10
1 Year	80.65 ± 80.50
5 Years	79.36 ± 81.20

Other pre-specifiedSubject's Average Serum LDH Measurement Over Time.

The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.

Time frame:: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Reported as:: Mean · U/L

Subject's Average Serum LDH Measurement Over Time.
U/L	INTUITY Aortic Valve and INTUITY Delivery System
Baseline	223.91 ± 53.0
3 Months	271.37 ± 87.20
1 Year	250.56 ± 76.20
5 Years	254.46 ± 76.30

Adverse events

Collected over Events occurring from baseline through five years post-implant. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
INTUITY Aortic Valve and INTUITY Delivery System	51/287 (17.8%)	233/287 (81.2%)	189/287 (65.9%)

Most frequent serious events

Showing 10 of 71

Most frequent serious events
Event	INTUITY Aortic Valve and INTUITY Delivery System
OtherGeneral disorders	137/287
Pulmonary - Pleural EffusionRespiratory, thoracic and mediastinal disorders	57/287
Infection - OtherInfections and infestations	37/287
Cardiac - OtherCardiac disorders	32/287
Cardiac - Atrial FibrillationCardiac disorders	32/287
Gastrointestinal - OtherGastrointestinal disorders	26/287
Other - AnemiaGeneral disorders	25/287
Cardiac - Heart FailureCardiac disorders	20/287
Cardiac - Other ArrhythmiaCardiac disorders	18/287
Cardiac - AV Block IIICardiac disorders	17/287

Most frequent other events

Showing 10 of 62

Most frequent other events
Event	INTUITY Aortic Valve and INTUITY Delivery System
OtherGeneral disorders	85/287
Infection - OtherInfections and infestations	45/287
Cardiac - Atrial FibrillationCardiac disorders	43/287
Pulmonary - Pleural EffusionRespiratory, thoracic and mediastinal disorders	16/287
Infection - LocalInfections and infestations	13/287
Gastrointestinal - OtherGastrointestinal disorders	12/287
Other - AnemiaGeneral disorders	11/287
Cardiac - BBB - Left CompleteCardiac disorders	9/287
Renal - Renal DysfunctionRenal and urinary disorders	9/287
Valvular - Mitral Regurgitation - MildCardiac disorders	9/287

Baseline characteristics

The outcome is reported for subjects who received the EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB where data is available.

Age, Continuous
Age, Continuous(years)	INTUITY Aortic Valve and INTUITY Delivery System
Mean	75.3 ± 6.7

Sex: Female, Male
Sex: Female, Male(Participants)	INTUITY Aortic Valve and INTUITY Delivery System
Female	141
Male	146

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	INTUITY Aortic Valve and INTUITY Delivery System

Study locations

6 sites

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna
Vienna, 1090, Austria
Kerchoff Klinik-Bad Nauheim
Bad Nauheim, 61231, Germany
Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie
Cologne, 50937, Germany
MHH-Medizinische Hoschschule Hannover
Hanover, 30625, Germany
University Leipzig: Herzzentrum Leipzig Gmbh
Leipzig, 04289, Germany
Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich
Munich, 81377, Germany

References and documents

Publications

Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103. PubMed 28453629 ↗
Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1. PubMed 25218544 ↗
Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8. PubMed 23058665 ↗
Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509. PubMed 29912142 ↗
Alaklabi AM, Abdul Rab S, Sabbah BN, Maklad AE, Dokollari A, Van den Eynde J, Pompeu Sa M, Arjomandi Rad A, Ahsan MR, Fatehi Hassanabad A. Innovations in Aortic Valve Replacement: A Comprehensive Overview of the Intuity Rapid Deployment Valve. Cardiol Rev. 2026 Jan-Feb 01;34(1):30-39. doi: 10.1097/CRD.0000000000000657. Epub 2024 Feb 9. PubMed 38334371 ↗

Study documents

Protocol and statistical analysis plan · Sep 15, 2011

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01445171
Lead sponsor: Edwards Lifesciences
Responsible party: Sponsor
First posted: Oct 3, 2011
Start date: Jan 2010
Primary completion: Dec 2017
Completion: Dec 2017
Results posted: Feb 17, 2020
Last update: Sep 1, 2023

Study contacts

Prof Axel Haverich

study director · MHH Hannover

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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