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C-Pulse IDE Feasibility Study- A Heart Assist System
NA trial testing C-Pulse™ (Implantable Counterpulsation Therapy) in Heart Failure in 21 participants. Completed in 7 September 2018.
| Lead sponsor | Nuwellis, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 10 September 2008 |
| Primary completion | 7 May 2018 |
| Estimated completion | 7 September 2018 |
| Sites | 6 locations across United States |
Nuwellis, Inc. — full company profile →
Adults 18 to 75, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.
| Group | Value | 95% CI |
|---|---|---|
| Implantable Counterpulsation Therapy | 3 |
6MWT in distance (meters).
| Group | Value | 95% CI |
|---|---|---|
| Implantable Counterpulsation Therapy | 299.8 | ± 102.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Implantable Counterpulsation Therapy | 1.06 | ± 0.11 |
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 K
| Group | Value | 95% CI |
|---|---|---|
| Implantable Counterpulsation Therapy | 63.3 | ± 20.6 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Implantable Counterpulsation Therapy | 4 | |
| Implantable Counterpulsation Therapy | 8 | |
| Implantable Counterpulsation Therapy | 4 | |
| Implantable Counterpulsation Therapy | 0 |
Time frame: 5 Years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Implantable Counterpulsati… |
|---|---|---|
| Major Infection | Infections and infestations | — |
| Cardiac Arrhythmias | Cardiac disorders | — |
| Worsening Left Heart Failure | Cardiac disorders | — |
Most-reported serious reactions: Major Infection, Cardiac Arrhythmias, Worsening Left Heart Failure.
Data from ClinicalTrials.gov NCT00815880 adverse events section.
The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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