Trial Outcomes & Findings for C-Pulse® System: A Heart Assist Device Clinical Study (NCT NCT01740596)
NCT ID: NCT01740596
Last Updated: 2024-01-11
Results Overview
The primary safety endpoint is serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
4 Years Follow-up
Results posted on
2024-01-11
Participant Flow
Unit of analysis: Implants
Participant milestones
| Measure |
C-Pulse® System Treatment Group
C-Pulse® System Counterpulsation: The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software.
\+ Continued Optimal Medical Therapy.
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Control Group
Continued Optimal Medical Therapy
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|---|---|---|
|
Overall Study
STARTED
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19 16
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19 0
|
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Overall Study
COMPLETED
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0 0
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0 0
|
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Overall Study
NOT COMPLETED
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19 16
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19 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
Baseline characteristics by cohort
| Measure |
Study Participants
n=35 Participants
Study participants consisted of Treatment Arm (n=17) who received the C-Pulse System and Control Arm (n=18) who received standard optimal medical therapy.
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|---|---|
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Age, Continuous
Treatment Arm
|
63.3 years
STANDARD_DEVIATION 11.7 • n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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Age, Continuous
Control Arm
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58.5 years
STANDARD_DEVIATION 8.2 • n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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Sex: Female, Male
Treatment Arm · Female
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2 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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Sex: Female, Male
Treatment Arm · Male
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15 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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Sex: Female, Male
Control Arm · Female
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4 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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Sex: Female, Male
Control Arm · Male
|
14 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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Race/Ethnicity, Customized
Treatment Arm · Black or African American
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5 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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Race/Ethnicity, Customized
Treatment Arm · Caucasian
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9 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Race/Ethnicity, Customized
Treatment Arm · Not Disclosed
|
3 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Race/Ethnicity, Customized
Control Arm · Black or African American
|
8 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Race/Ethnicity, Customized
Control Arm · Caucasian
|
9 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Race/Ethnicity, Customized
Control Arm · Not Disclosed
|
1 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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Region of Enrollment
United States
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35 Participants
n=35 Participants
|
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Intermacs Subject Profile/Status
Treatment Arm · 4: Resting Symptoms
|
0 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Treatment Arm · 5: Exertion Intolerant
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6 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Treatment Arm · 6: Exertion Limited
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7 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Treatment Arm · 7: Advanced NYHA Class III
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3 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Treatment Arm · Not Available
|
1 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Control Arm · 4: Resting Symptoms
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4 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Control Arm · 5: Exertion Intolerant
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3 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Control Arm · 6: Exertion Limited
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7 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Control Arm · 7: Advanced NYHA Class III
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1 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
|
Intermacs Subject Profile/Status
Control Arm · Not Available
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3 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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NYHA Classification
Treatment Arm · Class I
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0 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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NYHA Classification
Treatment Arm · Class II
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0 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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NYHA Classification
Treatment Arm · Class III
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17 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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NYHA Classification
Treatment Arm · Class IV
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0 Participants
n=17 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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NYHA Classification
Control Arm · Class I
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0 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
|
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NYHA Classification
Control Arm · Class II
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0 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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NYHA Classification
Control Arm · Class III
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18 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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NYHA Classification
Control Arm · Class IV
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0 Participants
n=18 Participants • There were 35 subjects analyzed in total with 17 in treatment arm and 18 in control.
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PRIMARY outcome
Timeframe: 4 Years Follow-upPopulation: Study was closed early with only 38 randomized subjects (19 treatment group and 19 control). Primary and secondary endpoints were not statistically evaluated as there was insufficient sample size and follow-up. The primary safety outcome was only applicable to the implant treatment arm as it is specifically measuring device and/or procedure related serious adverse events (control arm was treated as standard of care and did not undergo a procedure for the study device to be placed).
The primary safety endpoint is serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses.
Outcome measures
| Measure |
Study Participants
n=19 Participants
C-Pulse® System Treatment Group
|
Control Group
Continued Optimal Medical Therapy
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|---|---|---|
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Primary Safety Outcome
Device Related Serious Adverse Event (infection, device malfunction, worsening heart failure)
|
5 Participants
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—
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Primary Safety Outcome
Procedure Related Serious Adverse Events (MI, arrhythmias, fluid collection)
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6 Participants
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—
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SECONDARY outcome
Timeframe: 12-monthsPopulation: Number of participants that completed the 6MW
improvement of distance walked during the 6MW at 12-months.
Outcome measures
| Measure |
Study Participants
n=4 Participants
C-Pulse® System Treatment Group
|
Control Group
n=10 Participants
Continued Optimal Medical Therapy
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|---|---|---|
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Improvement in 6 Minute Hall Walk (6MW) at 12-months
|
279 meters
Standard Deviation 164
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289 meters
Standard Deviation 95
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SECONDARY outcome
Timeframe: 12-monthsPopulation: Number of participants with LVEF at 12-months.
Improvement in left ventricular ejection fraction (LVEF) at 12 months.
Outcome measures
| Measure |
Study Participants
n=5 Participants
C-Pulse® System Treatment Group
|
Control Group
n=8 Participants
Continued Optimal Medical Therapy
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|---|---|---|
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Improvement in LVEF at 12 Months.
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22.0 percentage
Standard Deviation 2.7
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22.0 percentage
Standard Deviation 7.6
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SECONDARY outcome
Timeframe: 12-monthsPopulation: Number of Participants that completed the KCCQ at 12-months.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a quality-of-life assessment for heart failure patients taking into consideration severity of heart failure symptoms and limitations patients experience. The scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Outcome measures
| Measure |
Study Participants
n=5 Participants
C-Pulse® System Treatment Group
|
Control Group
n=9 Participants
Continued Optimal Medical Therapy
|
|---|---|---|
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Improvement in KCCQ Score at 12-months.
|
61.4 score on a scale
Standard Deviation 23.1
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52.3 score on a scale
Standard Deviation 22.5
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Adverse Events
Treatment Group
Serious events: 16 serious events
Other events: 9 other events
Deaths: 10 deaths
Control Group
Serious events: 15 serious events
Other events: 1 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment Group
n=19 participants at risk
C-Pulse® System Treatment group
|
Control Group
n=19 participants at risk
Continued Optimal Medical Therapy
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|---|---|---|
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Infections and infestations
Major Infection
|
31.6%
6/19 • Number of events 13 • Up to 4 years of follow-up.
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15.8%
3/19 • Number of events 4 • Up to 4 years of follow-up.
|
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Cardiac disorders
Cardiac Disorders
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57.9%
11/19 • Number of events 21 • Up to 4 years of follow-up.
|
52.6%
10/19 • Number of events 10 • Up to 4 years of follow-up.
|
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Cardiac disorders
Worsening Heart Failure
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68.4%
13/19 • Number of events 28 • Up to 4 years of follow-up.
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68.4%
13/19 • Number of events 24 • Up to 4 years of follow-up.
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General disorders
Renal or Neuro Dysfunction
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42.1%
8/19 • Number of events 18 • Up to 4 years of follow-up.
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26.3%
5/19 • Number of events 7 • Up to 4 years of follow-up.
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Respiratory, thoracic and mediastinal disorders
Respiratory Failure
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5.3%
1/19 • Number of events 1 • Up to 4 years of follow-up.
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0.00%
0/19 • Up to 4 years of follow-up.
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Product Issues
Device Malfunction
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5.3%
1/19 • Number of events 1 • Up to 4 years of follow-up.
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0.00%
0/19 • Up to 4 years of follow-up.
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Other adverse events
| Measure |
Treatment Group
n=19 participants at risk
C-Pulse® System Treatment group
|
Control Group
n=19 participants at risk
Continued Optimal Medical Therapy
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|---|---|---|
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Cardiac disorders
Cardiac Disorders
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21.1%
4/19 • Number of events 4 • Up to 4 years of follow-up.
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0.00%
0/19 • Up to 4 years of follow-up.
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General disorders
General Disorders
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21.1%
4/19 • Number of events 5 • Up to 4 years of follow-up.
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5.3%
1/19 • Number of events 4 • Up to 4 years of follow-up.
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Infections and infestations
Infection
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21.1%
4/19 • Number of events 5 • Up to 4 years of follow-up.
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0.00%
0/19 • Up to 4 years of follow-up.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place