Heart Failure
Conditions
Keywords
heart failure, cardiac support, Paracor, HeartNet, PEERLESS-HF
Brief summary
The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm (Control group) after 6 months of follow-up.
Detailed description
In the United States alone, more than five million people suffer from heart failure (CHF) and an estimated 400,000 to 700,000 new cases are diagnosed each year. Caused by a variety of cardiac conditions, systolic heart failire (HF) is the end-stage of heart disease where the heart is failing as a pump. Once diagnosed with the disease, less than 50% of the patients live for five years, and less than 25% survive for more than ten years. The number of deaths in the United States from this condition has more than doubled since 1979, averaging more than 250,000 annually. Paracor Medical, Inc. has developed an elastic prosthetic wrap that is designed to apply a gentle mechanical support to the failing heart. The Implant is a compliant elastic structure that is designed to conform to the epicardial surface of the right and left ventricles. It supports the heart throughout the cardiac cycle and was designed to offload the ventricles and reduce wall stress. The objective of this clinical trial is to evaluate the safety and efficacy of the HeartNet Ventricular Support System with optimal medical and device therapy (Treatment group) when compared to optimal medical and device therapy (i.e., medications, cardiac resynchronisation therapy, pacemaker) alone (Control group) as treatments for patients with heart failure. Efficacy of the HeartNet Ventricular Support System in the Treatment group compared to the optimal medical and device therapy Control group will be evaluated based upon cardiopulmonary tests (Peak VO2), six (6) minute walk distance and quality of life assessment, as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire. Safety of the HeartNet Ventricular Support System in the Treatment group compared to the Control group will be evaluated based on the all-cause mortality rate. Paracor Medical intends to submit data obtained in this clinical trial to support a Pre-Market Approval Application to the United States Food and Drug Administration.
Interventions
DEVICEHeartNet Ventricular Support System
The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.
DRUGOptimal Medical/Device Therapy
Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.
Sponsors
Paracor Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic heart failure at enrollment (American College of Cardiology \[ACC\]/American Heart Association \[AHA\] Stage C) due to ischemic or nonischemic dilated cardiomyopathy 2. On stable, evidence-based medical and device therapy for heart failure for 3 months prior to randomization \<a\> Pharmacological Therapy (as appropriate) \<i\> angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB) for patients with ACE inhibitor intolerance or nitrate/hydralazine at the investigators discretion \<ii\> beta blockers \<iii\> diuretics, aldosterone inhibitors \<b\> Ejection fraction \< or = to 35% while maintained on optimal medical therapy \<c\> Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy-Defibrillator (CRT-D) \<i\> If implanted with a CRT or CRT-D, it must be implanted \> or = to 3 months before randomization \<ii\> If currently eligible or anticipated eligibility with a CRT or CRT-D within 6 months, the patient should not be enrolled in the study Specific Qualifying Characteristics 1. Six (6) minute walk of 150 - 450m 2. Peak VO2 for males: 10.0-20.0 ml/kg/min; Peak VO2 for females: 9.0-18.0 ml/kg/min 3. Left ventricular end diastolic diameter (LVEDD) \<85mm and index \<40mm/m2 (LVEDD/BSA) 4. Heart failure duration \> or = to 6 months
Exclusion criteria
Patient History 1. Heart failure due to a reversible condition 2. Hypertrophic obstructive cardiomyopathy (HOCM) 3. Left ventricular assist device (LVAD), intra-aortic balloon pump (IABP) or intravenous inotropes are required or the patient has end stage heart failure despite maintenance on best medical therapy 4. Myxoma 5. Active infection, sepsis, endocarditis, myocarditis or pericarditis 6. Myocardial infarction, stroke, transient ischemic attack, cardiac or other major surgery, or implantable cardioverter defibrillator (ICD) or pacemaker implantation in the 3 months prior to entry 7. Positive pregnancy test for pre-menopausal female 8. Less than 18 years or \> or = to 75 years old 9. Hemoglobin level less than 10 gm/dL or creatinine \>2.5 mg/dL 10. Uncontrolled medical conditions that increase surgical risk 11. Co-morbid condition that in the investigator's opinion reduces life expectancy to less than 2 years Surgical or Anatomical Considerations 1. Heart measurement too large or small for Implant sizes 2. Restrictive cardiomyopathy 3. Not a candidate for sternotomy or standard thoracotomy surgical approaches 4. Expected to have adhesions from previous surgical procedures 5. History of constrictive pericarditis 6. Previously placed coronary artery bypass grafts (CABG) or anticipated need for coronary artery bypass grafting 7. Not a candidate for cardiopulmonary bypass 8. Anatomical mitral valve regurgitation of 2+ or greater at the time of enrollment 9. Pulmonary function testing with the following results: Forced expiratory volume (FEV1) \<1L or if FEV1 is between 1 and 3L, forced expiratory volume divided by forced vital capacity (FEV1/FVC) \<60% 10. Cardiac or thoracic condition that might require operative correction. Cardiac transplantation is not included in this exclusion criterion. 11. Other elective surgical procedure at the time of the index hospitalization or within 30 days, whichever is longer Other 1. Any other medical condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure 2. Currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study 3. Unwilling/unable to comply with follow-up 4. Unwilling/unable to give signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Analysis - Peak Oxygen Uptake (Peak VO2) | Baseline to 6 months | A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline. |
| Responder Analysis - Six (6) Minute Walk (6MW) Distance | Baseline to 6 months | A participant was considered a responder if 6MW distance at 6 months was at least 45 meters more than at baseline. |
| Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | baseline to 6 months | A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score. |
| Number of Participant Deaths | 12 months | Total number of participants who died within 12 months of enrollment into the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Analysis - Six (6) Minute Walk (6MW) Distance | baseline to 12 Months | A participant was considered a responder if 6MW distance at 12 months was at least 45 meters more than at baseline. |
| Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | baseline to 12 months | A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score. |
| Heart Failure Hospitalization - Actuarial Analysis | 12 months | Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment |
| Change in Left Ventricular End Diastolic Volume | baseline to 6 months | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure. |
| Change in Left Ventricular End Systolic Volume | baseline to 6 months | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure. |
| Change in Ejection Fraction | baseline to 6 months | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented. |
| Change in Left Ventricular End Diastolic Diameter | baseline to 6 months | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure. |
| Change in Left Ventricular End Systolic Diameter | baseline to 6 months | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure. |
| Change in New York Heart Association (NYHA) Functional Class | baseline to 6 months | Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remained the same as baseline. Improved means the participant's functional class improved (became lower in number) by at least one class. Worsened means the participant's functional class deteriorated (became higher in number) by at least one class. |
| Heart Failure Death | 12 months | Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure |
| Heart Failure Death - Actuarial Analysis | 12 months | Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure |
| Heart Failure Hospitalization | 12 months | Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment. |
| All-Cause Hospitalization | 12 months | Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis. |
| All-Cause Hospitalization - Actuarial Analysis | 12 months | Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations |
| Participants Experiencing Serious Adverse Events | 12 months | Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment |
| Serious Adverse Events - Actuarial Analysis | 12 months | Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events |
| Days Alive Out of Hospital | 12 months | Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis. |
| Technical Success (Number of Treatment Arm Participants Successfully Implanted) | 1 day | Technical success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis. |
| Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | baseline to 6 months | The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented. |
| Change in Left Ventricular Mass | baseline to 6 months | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure. |
| Responder Analysis - Peak Oxygen Uptake (Peak VO2) | baseline to 12 months | A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline. |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects were recruited from 29 investigational sites in the US and 6 investigational sites in Canada, between November, 2006 to September, 2009
Pre-assignment details
3 subjects were considered Roll-in (not randomized) and received treatment. Data from these subjects are not included in the results. Seven (7) subjects were randomized to the Treatment group but were not treated due to suspension of the study. These subjects are excluded from the data.
Participants by arm
| Arm | Count |
|---|---|
| Treatment HeartNet and Optimal Medical/Device Therapy | 96 |
| Control Optimal Medical/Device Therapy alone | 114 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 9 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 25 |
Baseline characteristics
| Characteristic | Control | Total | Treatment |
|---|---|---|---|
| Age Continuous | 54.5 years STANDARD_DEVIATION 10.8 | 54.8 years STANDARD_DEVIATION 10.5 | 55.1 years STANDARD_DEVIATION 10.2 |
| Cardiac Medications ACE Inhibitors | 86 participants | 158 participants | 72 participants |
| Cardiac Medications Aldosterone Inhibitors | 76 participants | 129 participants | 53 participants |
| Cardiac Medications Antiogensin Receptor Blockers | 24 participants | 51 participants | 27 participants |
| Cardiac Medications Beta Blockers | 114 participants | 208 participants | 94 participants |
| Cardiac Medications Digoxin | 53 participants | 98 participants | 45 participants |
| Cardiac Medications Diuretics (other than Spironolactone) | 100 participants | 181 participants | 81 participants |
| Duration of Heart Failure (time) | 6.5 years STANDARD_DEVIATION 5 | 7.1 years STANDARD_DEVIATION 5.6 | 7.7 years STANDARD_DEVIATION 6.2 |
| Heart Failure Etiology Ischemic | 34 participants | 68 participants | 34 participants |
| Heart Failure Etiology Non-ischemic | 80 participants | 142 participants | 62 participants |
| Heart Failure Etiology Unknown | 0 participants | 0 participants | 0 participants |
| Medical History and Co-Morbidities Asthma | 11 participants | 22 participants | 11 participants |
| Medical History and Co-Morbidities Atrial Fibrillation | 28 participants | 50 participants | 22 participants |
| Medical History and Co-Morbidities Biventricular ICD | 57 participants | 98 participants | 41 participants |
| Medical History and Co-Morbidities Biventricular Pacemaker | 3 participants | 6 participants | 3 participants |
| Medical History and Co-Morbidities Chronic Obstructive Pulmonary Disease (COPD) | 13 participants | 21 participants | 8 participants |
| Medical History and Co-Morbidities Coronary Artery Disease with Angioplasty/Stent | 30 participants | 61 participants | 31 participants |
| Medical History and Co-Morbidities Diabetes Mellitus | 42 participants | 72 participants | 30 participants |
| Medical History and Co-Morbidities ICD alone | 45 participants | 87 participants | 42 participants |
| Medical History and Co-Morbidities ICD with Bradycardia Pacing Capability | 2 participants | 2 participants | 0 participants |
| Medical History and Co-Morbidities Myocardial Infarction | 33 participants | 68 participants | 35 participants |
| Medical History and Co-Morbidities Pacemaker alone | 1 participants | 1 participants | 0 participants |
| Medical History and Co-Morbidities Peripheral Vascular Disease | 1 participants | 4 participants | 3 participants |
| Medical History and Co-Morbidities Pulmonary Hypertension | 14 participants | 30 participants | 16 participants |
| Medical History and Co-Morbidities Sleep Apnea | 30 participants | 58 participants | 28 participants |
| Medical History and Co-Morbidities Stroke TIA/Other Thromboembolic Events | 9 participants | 21 participants | 12 participants |
| Medical History and Co-Morbidities Systemic Hypertension | 53 participants | 102 participants | 49 participants |
| Medical History and Co-Morbidities Ventricular Tachycardia | 40 participants | 68 participants | 28 participants |
| New York Heart Association (NYHA) Classification NYHA III; Marked limit to physical activity | 57 participants | 100 participants | 43 participants |
| New York Heart Association (NYHA) Classification NYHA II; Pts w/cardiac disease, slight limits | 53 participants | 102 participants | 49 participants |
| New York Heart Association (NYHA) Classification NYHA I: Pts w/cardiac disease, w/o activity limit | 4 participants | 7 participants | 3 participants |
| New York Heart Association (NYHA) Classification NYHA IV; inability to have activity w/o discomfort | 0 participants | 1 participants | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race (NIH/OMB) Asian | 3 participants | 5 participants | 2 participants |
| Race (NIH/OMB) Black or African American | 20 participants | 36 participants | 16 participants |
| Race (NIH/OMB) More than one race | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 1 participants | 1 participants |
| Race (NIH/OMB) White | 93 participants | 169 participants | 76 participants |
| Sex: Female, Male Female | 35 Participants | 63 Participants | 28 Participants |
| Sex: Female, Male Male | 79 Participants | 147 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 85 / 96 | 71 / 114 |
| serious Total, serious adverse events | 57 / 96 | 47 / 114 |
Outcome results
Primary
Number of Participant Deaths
Total number of participants who died within 12 months of enrollment into the trial.
Time frame: 12 months
Population: The population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Participant Deaths | 4 participants |
| Control | Number of Participant Deaths | 5 participants |
Comparison: The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.p-value: 0.012Exact binomial test
Primary
Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score
A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.
Time frame: baseline to 6 months
Population: The population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | 53 participants |
| Control | Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | 50 participants |
Comparison: The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.p-value: 0.184Fisher Exact
Primary
Responder Analysis - Peak Oxygen Uptake (Peak VO2)
A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline.
Time frame: Baseline to 6 months
Population: The population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Responder Analysis - Peak Oxygen Uptake (Peak VO2) | 31 participants |
| Control | Responder Analysis - Peak Oxygen Uptake (Peak VO2) | 35 participants |
Comparison: Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.p-value: 0.502Fisher Exact
Primary
Responder Analysis - Six (6) Minute Walk (6MW) Distance
A participant was considered a responder if 6MW distance at 6 months was at least 45 meters more than at baseline.
Time frame: Baseline to 6 months
Population: The population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Responder Analysis - Six (6) Minute Walk (6MW) Distance | 33 participants |
| Control | Responder Analysis - Six (6) Minute Walk (6MW) Distance | 25 participants |
Comparison: The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.p-value: 0.044Fisher Exact
Secondary
All-Cause Hospitalization
Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | All-Cause Hospitalization | 38 participants |
| Control | All-Cause Hospitalization | 45 participants |
p-value: 1Fisher Exact
Secondary
All-Cause Hospitalization - Actuarial Analysis
Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | All-Cause Hospitalization - Actuarial Analysis | 38 participants |
| Control | All-Cause Hospitalization - Actuarial Analysis | 45 participants |
p-value: 0.939Log Rank
Secondary
Change in Ejection Fraction
The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Ejection Fraction | 0.0 percent |
| Control | Change in Ejection Fraction | 1.9 percent |
p-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
Change in Left Ventricular End Diastolic Diameter
The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Left Ventricular End Diastolic Diameter | -0.15 centimeters |
| Control | Change in Left Ventricular End Diastolic Diameter | 0 centimeters |
p-value: 0.015Wilcoxon (Mann-Whitney)
Secondary
Change in Left Ventricular End Diastolic Volume
The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Left Ventricular End Diastolic Volume | -3.8 milliliters |
| Control | Change in Left Ventricular End Diastolic Volume | 10.9 milliliters |
p-value: 0.031Wilcoxon (Mann-Whitney)
Secondary
Change in Left Ventricular End Systolic Diameter
The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Left Ventricular End Systolic Diameter | -0.1 centimeters |
| Control | Change in Left Ventricular End Systolic Diameter | 0.1 centimeters |
p-value: 0.032Wilcoxon (Mann-Whitney)
Secondary
Change in Left Ventricular End Systolic Volume
The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Left Ventricular End Systolic Volume | -7.0 milliliters |
| Control | Change in Left Ventricular End Systolic Volume | 2.75 milliliters |
p-value: 0.179Wilcoxon (Mann-Whitney)
Secondary
Change in Left Ventricular Mass
The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Left Ventricular Mass | -19.0 grams |
| Control | Change in Left Ventricular Mass | 7.0 grams |
p-value: 0.032Wilcoxon (Mann-Whitney)
Secondary
Change in New York Heart Association (NYHA) Functional Class
Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remained the same as baseline. Improved means the participant's functional class improved (became lower in number) by at least one class. Worsened means the participant's functional class deteriorated (became higher in number) by at least one class.
Time frame: baseline to 6 months
Population: Population is intent to treat.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Change in New York Heart Association (NYHA) Functional Class | Improved | 37 participants |
| Treatment | Change in New York Heart Association (NYHA) Functional Class | Maintained | 45 participants |
| Treatment | Change in New York Heart Association (NYHA) Functional Class | Worsened | 9 participants |
| Control | Change in New York Heart Association (NYHA) Functional Class | Improved | 29 participants |
| Control | Change in New York Heart Association (NYHA) Functional Class | Maintained | 59 participants |
| Control | Change in New York Heart Association (NYHA) Functional Class | Worsened | 15 participants |
Comparison: Class change from baseline.p-value: 0.052Wilcoxon (Mann-Whitney)
Secondary
Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.
Time frame: baseline to 6 months
Population: Population is intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12.6 score on a scale | Standard Deviation 18.2 |
| Control | Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 3.4 score on a scale | Standard Deviation 16.8 |
p-value: <0.001t-test, 2 sided
Secondary
Days Alive Out of Hospital
Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Days Alive Out of Hospital | 365 days |
| Control | Days Alive Out of Hospital | 365 days |
p-value: 0.772Wilcoxon (Mann-Whitney)
Secondary
Heart Failure Death
Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Heart Failure Death | 1 participants |
| Control | Heart Failure Death | 3 participants |
p-value: 0.627Fisher Exact
Secondary
Heart Failure Death - Actuarial Analysis
Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Heart Failure Death - Actuarial Analysis | 1 participants |
| Control | Heart Failure Death - Actuarial Analysis | 3 participants |
p-value: 0.386Log Rank
Secondary
Heart Failure Hospitalization
Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Heart Failure Hospitalization | 9 participants |
| Control | Heart Failure Hospitalization | 19 participants |
p-value: 0.154Fisher Exact
Secondary
Heart Failure Hospitalization - Actuarial Analysis
Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Heart Failure Hospitalization - Actuarial Analysis | 9 participants |
| Control | Heart Failure Hospitalization - Actuarial Analysis | 19 participants |
Comparison: Kaplan-Meier actuarial time-to-first-event analysisp-value: 0.109Log Rank
Secondary
Participants Experiencing Serious Adverse Events
Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Participants Experiencing Serious Adverse Events | 57 participants |
| Control | Participants Experiencing Serious Adverse Events | 47 participants |
p-value: 0.012Fisher Exact
Secondary
Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score
A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.
Time frame: baseline to 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | 52 participants |
| Control | Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | 43 participants |
Comparison: Improvement of at least 7 points from baseline.p-value: 0.031Fisher Exact
Secondary
Responder Analysis - Peak Oxygen Uptake (Peak VO2)
A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline.
Time frame: baseline to 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Responder Analysis - Peak Oxygen Uptake (Peak VO2) | 19 participants |
| Control | Responder Analysis - Peak Oxygen Uptake (Peak VO2) | 21 participants |
Comparison: Improvement of at least 1.0 ml/kg/min from baseline.p-value: 0.54Fisher Exact
Secondary
Responder Analysis - Six (6) Minute Walk (6MW) Distance
A participant was considered a responder if 6MW distance at 12 months was at least 45 meters more than at baseline.
Time frame: baseline to 12 Months
Population: Population is intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Responder Analysis - Six (6) Minute Walk (6MW) Distance | 33 participants |
| Control | Responder Analysis - Six (6) Minute Walk (6MW) Distance | 25 participants |
Comparison: Improvement of at least 45 m from baseline.p-value: 0.067Fisher Exact
Secondary
Serious Adverse Events - Actuarial Analysis
Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events
Time frame: 12 months
Population: Population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Serious Adverse Events - Actuarial Analysis | 57 participants |
| Control | Serious Adverse Events - Actuarial Analysis | 47 participants |
p-value: 0.001Log Rank
Secondary
Technical Success (Number of Treatment Arm Participants Successfully Implanted)
Technical success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis.
Time frame: 1 day
Population: Population is as treated, treatment only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Technical Success (Number of Treatment Arm Participants Successfully Implanted) | 92 participants |