An interventional study of Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD) in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 52 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-09.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Treatment
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the force with which the heart pumps blood (heart pressures). When combined with the ICD, the device has the additional ability to send a strong electrical impulse, or shock, to the heart when it detects dangerously fast heartbeats to return it to a normal rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest area. This study will also determine how doctors use the information related to heart pressures in the management of heart failure.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 442 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be considered for Chronicle ICD: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
Exclusion Criteria:
Subjects in concurrent studies that may confound the results.
(3)Class IV Subjects 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. If any physical activity is undertaken, discomfort is increased.
(4)Stage D refractory heart failure: Patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)
Physicians have access to device-based hemodynamic monitor information to guide patient management
Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.
Also known as: Chronicle® IHM, Chronicle® ICD
Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.
A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.
Time frame: Within 6 months post-implant
Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant
A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.
Time frame: 6 months post implant
Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group
The rate of HF-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.
Time frame: 12 months post-implant
Cumulative Days in the Hospital for Heart Failure
The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.
Time frame: 12 months post-implant
Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group
The rate of CV-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.
Time frame: 12 months post-implant
Freedom From All Cause Death or Heart Failure Hospitalization
Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period
Time frame: 12 months post-implant
Relative Risk of All-cause Events
All-cause events were defined as hospitalizations, hospitalizations \<24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.
Time frame: 12 months post-implant
Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.
The definitions of worsened, improved, and unchanged are as follows: Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF. Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score. Unchanged: Subject is neither worsened nor improved.
Time frame: 12 months post implant
Characterize Health Resource Utilization
Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.
Time frame: 12 months post implant
Characterize Randomized Days Alive Out of Hospital
Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.
Time frame: 12 months post implant
Characterize Subject Survival
Death from any cause during the 12-month randomization period
Time frame: 12 months post implant
Characterize Medication Usage
The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.
Time frame: 12 months post implant
Characterize Intracardiac Pressure
The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.
Time frame: 12 months post implant
Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events
The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.
Time frame: 12 months post implant
Characterize NYHA Functional Class
The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.
Time frame: baseline to 12 months post implant
Characterize Distance Walked in Six Minutes
The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.
Time frame: baseline to 12 months post implant
Characterize Renal Function at the Baseline and 12-month Visit
Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.
Time frame: baseline to 12 months post implant
Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)
Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.
Time frame: implant
Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)
The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin
Time frame: Implant
Characterize Quality of Life at Baseline and 12-month Visit
The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.
Time frame: baseline to 12 months post implant
Characterize Arrhythmic Events
The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm
Time frame: 12 months post implant
Recruitment began on April 28, 2006 and ended on January 14, 2011. All subjects were exited from the study on January 14, 2011. Fifty-three US clinical centers participated in the REDUCEhf study.
| Milestone | Treatment Arm | Control Arm |
|---|---|---|
| Started | 202 | 198 |
| Completed | 180 | 176 |
| Not completed | 22 | 22 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Physician decision | 6 | 10 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Death | 7 | 9 |
| Milestone | Treatment Arm | Control Arm |
|---|---|---|
| Started | 180 | 176 |
| Completed | 0 | 0 |
| Not completed | 180 | 176 |
| Withdrew: Withdrawal by subject | 9 | 9 |
| Withdrew: Physician decision | 127 | 122 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Death | 14 | 11 |
| Withdrew: Study closed | 29 | 34 |
A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.
| Percentage of Chronicle ICD Subjects | Chronicle ICD Implanted Subjects |
|---|---|
| Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant. | 90.5 (87.7 to 93.4) |
A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.
| Percent of Chronicle IHM subjects | Chronicle IHM Implanted Subjects |
|---|---|
| Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant | 100 (100 to 100) |
The rate of HF-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.
| Heart failure related events per year | Treatment Arm | Control Arm |
|---|---|---|
| Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group | 0.48 (0.38 to 0.58) | 0.49 (0.39 to 0.59) |
The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.
| Percent days in hospital | Treatment Arm | Control Arm |
|---|---|---|
| Cumulative Days in the Hospital for Heart Failure | 0 (0 to 22) | 0 (0 to 43) |
The rate of CV-related events (hospitalizations \>24h, hospitalizations \<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.
| Cardiovascular related events per year | Treatment Arm | Control Arm |
|---|---|---|
| Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group | 0.77 (0.64 to 0.89) | 0.86 (0.71 to 0.98) |
Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period
| Number of subjects meeting endpoint | Treatment Arm | Control Arm |
|---|---|---|
| Freedom From All Cause Death or Heart Failure Hospitalization | 42 (0.73 to 0.85) | 47 (0.70 to 0.82) |
All-cause events were defined as hospitalizations, hospitalizations \<24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.
| All cause event rate per year | Treatment Arm | Control Arm |
|---|---|---|
| Relative Risk of All-cause Events | 1.18 (1.03 to 1.34) | 1.55 (1.36 to 1.72) |
The definitions of worsened, improved, and unchanged are as follows: Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF. Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score. Unchanged: Subject is neither worsened nor improved.
| Percent of Subjects | Treatment Arm | Control Arm |
|---|---|---|
| Percent Subjects Improved | 51 | 51 |
| Percent Subjects Unchanged | 19 | 17 |
| Percent Subjects Worsened | 30 | 32 |
Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.
| percentage of randomized days | Treatment Arm | Control Arm |
|---|---|---|
| Characterize Health Resource Utilization | 0.1 (0 to 5.3) | 0.4 (0 to 35.1) |
Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.
| Days | Treatment Arm | Control Arm |
|---|---|---|
| Characterize Randomized Days Alive Out of Hospital | 340 ± 65 | 341 ± 63 |
Death from any cause during the 12-month randomization period
| number of deaths | Treatment Arm | Control Arm |
|---|---|---|
| Characterize Subject Survival | 7 | 9 |
The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.
| Medication changes per subject month | Treatment Arm | Control Arm |
|---|---|---|
| Characterize Medication Usage | 1.77 | 1.49 |
The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.
| ePAD mm Hg | Treatment Arm | Control Arm |
|---|---|---|
| Characterize Intracardiac Pressure | 22.0 ± 5.6 | 23.3 ± 6.5 |
The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.
| ePAD mm Hg | Heart Failure Event Free Control Subjects | Heart Failure Event Control Subjects |
|---|---|---|
| Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events | 26.3 ± 6.5 | 22.5 ± 6.3 |
The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.
| percentage of subjects | Treatment Arm | Control Arm |
|---|---|---|
| Percent Subjects NYHA Class II Baseline | 55 (36 to 51) | 48 (33 to 48) |
| Percent Subjects NYHA Class III Baseline | 45 | 52 |
| Percent Subjects NYHA Class I Month 12 | 24 | 17 |
| Percent Subjects NYHA Class II Month 12 | 46 | 52 |
| Percent Subjects NYHA Class III Month 12 | 27 | 28 |
| Percent Subjects NYHA Class IV Month 12 | 2 | 5 |
| Percent Subjects Improved NYHA Class | 44 | 41 |
| Percent Subjects No Change in NYHA Class | 45 | 49 |
| Percent Subjects Worsened NYHA Class | 12 | 10 |
The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.
| distance walked in 6-minutes (meters) | Treatment Arm | Control Arm |
|---|---|---|
| Baseline visit | 313.2 ± 124.8 | 308.7 ± 133.5 |
| 12-month visit | 354.5 ± 178.8 | 347.2 ± 160.4 |
| Change from baseline to 12-months | 41.3 ± 160.5 | 38.5 ± 154.3 |
Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.
| mL/min/1.73 m^2 | Treatment Arm | Control Arm |
|---|---|---|
| Baseline eGFR | 72.4 ± 26.2 | 69.8 ± 20.4 |
| 12-month eGFR | 68.6 ± 27.7 | 69.2 ± 25.6 |
| Change in eGFR from baseline to 12-months | -3.8 ± 22.0 | -0.6 ± 19.3 |
Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.
| Percentage of subjects with waveforms | Chronicle ICD Implanted Subjects |
|---|---|
| Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only) | 99.7 (98.5 to 100) |
The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin
| percentage of subjects | Chronicle ICD Implanted Subjects |
|---|---|
| Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only) | 98.9 (97.2 to 99.7) |
The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.
| scores on a scale | Treatment Arm | Control Arm |
|---|---|---|
| Baseline MNWHF score | 49.7 ± 26.4 | 52.7 ± 28.0 |
| 12-month MNWHF score | 34.0 ± 25.6 | 37.2 ± 25.9 |
| Change in MNWHF score from baseline | -15.7 ± 27.3 | -15.6 ± 23.7 |
The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm
| VT/VF episodes per subject month | Treatment Arm | Control Arm |
|---|---|---|
| Characterize Arrhythmic Events | 0.54 (0.43 to 0.64) | 0.38 (0.29 to 0.47) |
Collected over Time from enrollment through study closure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | — | 123/202 (60.9%) | 24/202 (11.9%) |
| Control Arm | — | 136/198 (68.7%) | 25/198 (12.6%) |
| Enrolled, Not Randomized | — | 8/42 (19%) | 0/42 (0%) |
| Event | Treatment Arm | Control Arm | Enrolled, Not Randomized |
|---|---|---|---|
| CARDIAC FAILURECardiac disorders | 60/202 | 63/198 | 4/42 |
| RENAL FAILURE ACUTERenal and urinary disorders | 10/202 | 18/198 | 3/42 |
| ANGINA PECTORISCardiac disorders | 14/202 | 12/198 | 0/42 |
| VENTRICULAR TACHYCARDIACardiac disorders | 8/202 | 11/198 | 0/42 |
| ATRIAL FIBRILLATIONCardiac disorders | 5/202 | 10/198 | 1/42 |
| PNEUMONIAInfections and infestations | 8/202 | 8/198 | 0/42 |
| HYPOTENSIONVascular disorders | 8/202 | 4/198 | 1/42 |
| LEAD DISLODGEMENTInjury, poisoning and procedural complications | 5/202 | 7/198 | 0/42 |
| IMPLANT SITE HAEMATOMAGeneral disorders | 0/202 | 6/198 | 0/42 |
| NON-CARDIAC CHEST PAINGeneral disorders | 5/202 | 6/198 | 0/42 |
| Event | Treatment Arm | Control Arm | Enrolled, Not Randomized |
|---|---|---|---|
| CARDIAC FAILURECardiac disorders | 24/202 | 25/198 | 0/42 |
| Age, Categorical(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 151 | 144 | 295 |
| >=65 years | 51 | 54 | 105 |
| Age Continuous(years) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 54.8 ± 14.7 | 54.7 ± 14.8 | 54.7 ± 14.7 |
| Sex: Female, Male(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Female | 61 | 65 | 126 |
| Male | 141 | 133 | 274 |
| Region of Enrollment(participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| United States | 202 | 198 | 400 |
| NYHA (New York Heart Association) Classification(participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| NYHA Class II | 107 | 90 | 197 |
| NYHA Class III | 95 | 108 | 203 |
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Medtronic Cardiac Rhythm and Heart Failure