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C-Pulse® System: A Heart Assist Device Clinical Study

NCT01740596 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-01-11

Study results available
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Summary

Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").

The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the device in the United States.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Nuwellis, Inc.

    lead INDUSTRY

Principal Investigators

  • William Abraham, MD · Ohio State University

  • Margarita T Camacho, MD · Newark Beth Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-12
Primary Completion
2018-09-19
Completion
2018-10-26

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 NCT01740596 on ClinicalTrials.gov