CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
C-Pulse™ (Implantable Counterpulsation Therapy)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00815880
NCT00815880N/ACompleted
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C-Pulse Implantable Counterpulsation Pump (ICP) Feasibility Study - A Heart Assist System

Nuwellis, Inc.·interventional·Posted Dec 31, 2008·Updated Aug 24, 2023

In Brief

A clinical study evaluating C-Pulse™ (Implantable Counterpulsation Therapy) for Heart Failure. Completed, enrolled 21 participants across 6 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2008
Enrollment StartSep 10, 2008
Primary CompletionMay 7, 2018
Study CompletionSep 7, 2018
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 17.5 years ago

Interventions

C-Pulse™ (Implantable Counterpulsation Therapy)device

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.