Trial Outcomes & Findings for C-Pulse IDE Feasibility Study- A Heart Assist System (NCT NCT00815880)
NCT ID: NCT00815880
Last Updated: 2023-08-24
Results Overview
Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.
COMPLETED
NA
21 participants
5 Years
2023-08-24
Participant Flow
The C-Pulse IDE feasibility study is a multi-center study in up to seven (7) centers in the United States and one (1) Outside the United States center (Canada). 21 subjects were enrolled and implanted.
Participant milestones
| Measure |
Implantable Counterpulsation Therapy
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and will receive the C-Pulse System Implant as intervention therapy.There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The period of follow- up will be 6 months to assess the safety and performance before initiating the pivotal randomized clinical trial. All patients will continue to be followed annually during long term follow-up to a minimum of 5 years.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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3
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Overall Study
NOT COMPLETED
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18
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject did not provide information about Race.
Baseline characteristics by cohort
| Measure |
Implantable Counterpulsation Therapy
n=21 Participants
A total of 21 patients were treated with C-Pulse implantable counterpulsation. The study follow-up period was up to 5 years. Only 3 subjects completed the 60 month follow-up visit, and 18 subjects prematurely exited the study prior to the 60 month follow-up.
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|---|---|
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Age, Customized
18-75 years
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21 Participants
n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants • One subject did not provide information about Race.
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants • One subject did not provide information about Race.
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants • One subject did not provide information about Race.
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Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants • One subject did not provide information about Race.
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Race (NIH/OMB)
White
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17 Participants
n=5 Participants • One subject did not provide information about Race.
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants • One subject did not provide information about Race.
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants • One subject did not provide information about Race.
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Region of Enrollment
United States
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18 participants
n=5 Participants
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Region of Enrollment
Canada
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3 participants
n=5 Participants
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Intermacs Subject Profile/Status
3: Stable but Inotrope Dependent
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3 Participants
n=5 Participants
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Intermacs Subject Profile/Status
4: Resting Symptoms
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1 Participants
n=5 Participants
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Intermacs Subject Profile/Status
5: Exertion Intolerant
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8 Participants
n=5 Participants
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Intermacs Subject Profile/Status
6: Exertion Limited
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7 Participants
n=5 Participants
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Intermacs Subject Profile/Status
7: Advanced NYHA Class 3
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2 Participants
n=5 Participants
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NYHA Classification
III
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19 Participants
n=5 Participants
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NYHA Classification
IV
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2 Participants
n=5 Participants
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Cardiomyopathy Etiology
Ischemic
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7 Participants
n=5 Participants
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Cardiomyopathy Etiology
Non-Ischemic
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14 Participants
n=5 Participants
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Cardiac Resynchronization Therapy (CRT)
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10 Participants
n=5 Participants
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Implantable Cardioverter Defibrillator (ICD) Therapy
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21 Participants
n=5 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ)
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39.6 Overall Score
STANDARD_DEVIATION 19.4 • n=5 Participants
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Six Minute Walking Test (6MWT)
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273.4 meters
STANDARD_DEVIATION 63.1 • n=5 Participants
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Cardiopulmonary Exercise Testing (CPX)
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1.07 Respiratory Exchange Ratio (RER)
STANDARD_DEVIATION 0.10 • n=5 Participants
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PRIMARY outcome
Timeframe: 5 YearsAmount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.
Outcome measures
| Measure |
Implantable Counterpulsation Therapy
n=21 Participants
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
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|---|---|
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Number of Surviving Participants That Completed the Study
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3 Participants
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: 16 subjects were enrolled with implants at the 6 month follow-up date.
6MWT in distance (meters).
Outcome measures
| Measure |
Implantable Counterpulsation Therapy
n=16 Participants
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
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|---|---|
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Six Minute Walk Test
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299.8 meters
Standard Deviation 102.3
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: 16 subjects were enrolled and implanted at the 6 month follow-up date, but only 15 were able to perform the Cardiopulmonary Exercise Testing.
CPX is performed on a treadmill and carried out to a symptomatic maximum. Minute oxygen consumption (VO2; ml/min) and minute carbon dioxide production (VCO2; ml/min) are measured using a breath-by-breath respiratory gas analyzer. The Respiratory Exchange Ratio (RER) is calculated as VCO2/VO2. A peak RER of ≥1.10 is generally considered an indication of excellent subject effort during CPX. Achievement of a peak RER \<1.00 in a CPX that is terminated by subject request, absent any electrocardiographic or hemodynamic abnormalities, generally reflects submaximal cardiovascular effort.
Outcome measures
| Measure |
Implantable Counterpulsation Therapy
n=15 Participants
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
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|---|---|
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Cardiopulmonary Exercise Testing
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1.06 Respiratory Exchange Ratio (RER)
Standard Deviation 0.11
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: 16 subjects were enrolled and implanted at the 6 month follow-up date.
Overall KCCQ score, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status.The KCCQ instrument may be used by medical device companies and sponsor-investigators for evaluation of safety and effectiveness for heart failure medical devices to support regulatory submissions. The KCCQ instrument, specifically the Symptom Domain Score, Physical Limitation Domain Score, Social Limitation Domain Score, Quality of Life Domain Score and Overall Summary Score, can be used as a component of a composite primary endpoint or secondary endpoint in a feasibility or pivotal clinical trial evaluating heart failure medical devices.
Outcome measures
| Measure |
Implantable Counterpulsation Therapy
n=16 Participants
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
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|---|---|
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Kansas City Cardiomyopathy Questionnaire (KCCQ)
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63.3 score on a scale
Standard Deviation 20.6
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SECONDARY outcome
Timeframe: 6 MonthsPopulation: 16 subjects were still enrolled with implants at the 6 month follow-up date.
The most commonly used heart failure classification system, the NYHA Functional Classification, classifies patients' heart failure according to the severity of their symptoms. It places patients in one of four categories based on how much they are limited during physical activity (I: No limitation of physical activity, II: Slight limitation of physical activity and comfortable at rest, III: Marked limitation of physical activity and comfortable at rest, IV: Unable to carry on any physical activity without discomfort, and symptoms of heart failure at rest).
Outcome measures
| Measure |
Implantable Counterpulsation Therapy
n=16 Participants
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
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|---|---|
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New York Heart Association (NYHA) Classification
I
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4 Participants
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New York Heart Association (NYHA) Classification
II
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8 Participants
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New York Heart Association (NYHA) Classification
III
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4 Participants
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New York Heart Association (NYHA) Classification
IV
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0 Participants
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Adverse Events
Implantable Counterpulsation Therapy
Serious adverse events
| Measure |
Implantable Counterpulsation Therapy
n=21 participants at risk
The study is a single arm study with 21 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and will receive the C-Pulse System Implant as intervention therapy.There is not a control arm in this feasibility study.
C-Pulse™ (Implantable Counterpulsation Therapy): Implantation and activation of counterpulsation therapy for the full duration of the study period. The period of follow- up will be 6 months to assess the safety and performance before initiating the pivotal randomized clinical trial. All patients will continue to be followed annually during long term follow-up to a minimum of 5 years.
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|---|---|
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Cardiac disorders
Cardiac Arrhythmias
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38.1%
8/21 • Number of events 16 • 5 Years
Adverse events for the C-Pulse feasibility study are reported using the INTERMACS© definitions as a guideline.
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Cardiac disorders
Worsening Left Heart Failure
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23.8%
5/21 • Number of events 7 • 5 Years
Adverse events for the C-Pulse feasibility study are reported using the INTERMACS© definitions as a guideline.
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Infections and infestations
Major Infection
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71.4%
15/21 • Number of events 32 • 5 Years
Adverse events for the C-Pulse feasibility study are reported using the INTERMACS© definitions as a guideline.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place