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C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device

NCT01176370 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-08-15

No results posted yet for this study

Summary

The C-Pulse 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)

C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device.

Sponsors & Collaborators

  • Nuwellis, Inc.

    lead INDUSTRY

Principal Investigators

  • Renzo Cecere, MD · McGill University Health Centre, Royal Victoria Hospital

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
2010-06-21
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Canada

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 NCT01176370 on ClinicalTrials.gov