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C-Pulse IDE Feasibility Study- A Heart Assist System

NCT00815880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-08-24

Study results available
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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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Nuwellis, Inc.

    lead INDUSTRY

Principal Investigators

  • William T Abraham, MD · Ohio State University

  • Pat McCarthy, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-10
Primary Completion
2018-05-07
Completion
2018-09-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815880 on ClinicalTrials.gov