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Study Status: 
Open
Study Description: 

Enrollment in this study is temporarily on hold.

This clinical trial is for men and women moderate to severe heart failure (HF). The purpose of the study is to assess the safety and efficacy of the C-Pulse System, a device that is intended to relieve heart failure symptoms, improve quality of life and cardiac function, and reduce the need for heart failure hospitalization.

Unlike traditional heart assist devices, the C-Pulse system includes a small cuff around the aorta that inflates and deflates as the heart beats, increasing the heart’s oxygen supply and reducing the stress on the pumping chamber.  It is implanted outside the bloodstream, and maybe disconnected for personal hygiene.

Study subjects are follow up for five years after the device is implanted.

Key Eligibility: 

Men and women age 18 and older diagnosed with heart failure of ACC/AHA Stage C and NYHA III to ambulatory Class IV, who have:

  • Left ventricular ejection fraction (LVEF) ≤ 35
  • Functional limitation measured by 6 Minute Walk test between 175 and 375 meters
  • Stable, up-titrated medical therapy as recommended according to current guidelines
  • At least one heart failure-related hospitalization in the past 12 months

Detailed eligibility requirements will be reviewed when you contact the study team.

Principal Investigator: 
Evelyn Horn, M.D.
Contact: 

Melissa D. Ricketts, CCRC, phone 212-746-2698, email mdr2001@med.cornell.edu

Sponsor: 
Biosense Webster, Inc.
Official Title: 

C-Pulse Heart Assist Device Pivotal Study Treating Patients With Moderate to Severe Heart Failure C-Pulse® System: A Heart Assist Device Pivotal IDE Study. ClinicalTrials.gov Identifier NCT01626079 

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