TerminatedNot Applicable

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

Stopped: The study was stopped early due to a business decision to no longer pursue commercialization of the C-PULSE System. This decision was not based on any safety concerns.

United States38 participantsStarted 2012-09-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Left ventricular ejection fraction (LVEF) ≤ 35% (by transthoracic ECHO within 90 days prior to randomization)
✓. ACC/AHA Stage C and NYHA III to ambulatory Class IV
✓. Age ≥ 18 years
✓. Must have cardiac resynchronization therapy (CRT) when clinically indicated, implanted ≥90 days prior to randomization.
✓. Must have an implanted cardio-defibrillator (ICD) when clinically indicated, implanted at least 30 days prior to randomization.
✓. Patient must be on stable, up-titrated medical therapy as recommended according to current guidelines (Circulation. 2009; 119 (12): 1977-2016) which minimally includes:
✓. Functional limitation due to heart failure as defined by a 6 Minute Walk test of ≥ 175 ≤ 375 meters, measured within 30 days prior to randomization
✓. At least one hospitalization for decompensated heart failure as defined below, while on heart failure medications, within 12 months prior to randomization or BNP level \> 300 or NTproBNP \> 1500

Exclusion criteria

What they're measuring

Primary Safety Outcome

Timeframe: 4 Years Follow-up

Trial details

NCT IDNCT01740596

SponsorNuwellis, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-19

Results submitted2022-05-14

View on ClinicalTrials.gov More Heart Failure trials