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

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01740596

Run by

Nuwellis, Inc.

People needed

38

Starts

2012-09-12

Expected to finish

2018-10-26

Last updated by the study team

2024-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Note: If a subject is clinically indicated for an ICD but refuses the ICD, he/she may be enrolled. Please document the refusal of the ICD in the medical record and the eCRFs.
• Patient must be on stable, up-titrated medical therapy as recommended according to current guidelines (Circulation. 2009; 119 (12): 1977-2016) which minimally includes:
• ACE-inhibitor (ACE-I) at stable doses for 1 month prior to enrollment, if tolerated, AND
• a beta blocker (carvedilol, sustained release metoprolol succinate, or bisoprolol) for 3 months prior to enrollment, if tolerated, with a stable up-titrated dose for 1 month prior to enrollment.
• This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for 1 month prior to enrollment, if tolerated, when ACE-I is not tolerated.
• Stable is defined as no more than a 100% increase or a 50% decrease in dose. If the patient is intolerant to ACE-I, ARB, or beta blockers, documented evidence must be available.
• In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timelines.
• Aldosterone inhibitor therapy should be added. Eplerenone requires dosage stability for 1 month prior to enrollment.
• Diuretics may be used as necessary to keep the patient euvolemic.
• 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
• Heart failure related hospitalization is defined by the following:
• signs and symptoms of worsening heart failure; and
• treatment with intravenous heart failure therapy (including but not limited to diuretic or inotropic therapy) and
• a minimum of one date change in the hospital
• Patient understands the nature of the procedure and on-going device therapy, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure.

You may not qualify if…

• Any evidence, as assessed within 90 days prior to enrollment, of either:
• Ascending aortic calcification on posterior-anterior or lateral chest x-ray
• Calcific ascending aortic disease as detected by non-contrast CT scan
• Ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or repaired aortic coarctation OR
• Has had an ascending aortic composite graft or root replacement
• Aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 28 mm or greater than 42 mm
• Inotrope dependence - inability to wean from inotropic therapy
• ACC/AHA Stage D heart failure or non-ambulatory NYHA Class IV subject
• Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, diastolic heart failure or technically challenging congenital heart disease
• Reversible cause of heart failure that may be remedied by conventional surgery or other intervention
• Moderate to severe aortic insufficiency (≥ 2+)
• ST elevation myocardial infarction (STEMI) within 30 days prior to randomization
• Cardiac surgery within 90 days prior to randomization
• Prior cardiac transplantation, left ventricular reduction surgery, passive restraint device or surgically implanted left ventricular assist device
• Anticipated concomitant cardiac surgical procedure
• Serum creatinine ≥ 2.5mg/dL or any form of dialysis within 30 days prior to randomization
• Evidence of intrinsic hepatic disease as defined as biopsy proven liver cirrhosis; or liver enzyme values (AST, ALT or total bilirubin) that are > 3 times the upper limit of normal within 30 days prior to randomization
• Patient has severe intrinsic pulmonary disease in judgment of the investigator
• Body Mass Index (BMI) < 18 or > 45 kg/m2
• Suspected or active systemic infection
• Within 14 days prior to randomization and
• Evidenced by positive culture, antibiotics for empiric treatment or elevated WBC > 12K and temperature >38o C
• Stroke or transient ischemic attack (TIA) within the 90 days prior to randomization; or > 80% carotid stenosis as determined by carotid Doppler ultrasound within 90 days prior to randomization
• Positive serum pregnancy test, for women of childbearing potential
• Patient has a condition, other than heart failure, which would limit survival to less than 2 years

Where it is running

• The University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
• University of Southern California Keck School of Medicine — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• University of Miami Medical Center — Miami, Florida, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• University of Louisville - Jewish Hospital — Louisville, Kentucky, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mid America Heart Institute-Saint Luke's Hospital — Kansas City, Missouri, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Cornell University, New York - Presbyterian Hospital — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Charlotte-Mecklenburg Hospital - Carolinas Health Care System — Charlotte, North Carolina, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Allegheny-Singer Research Institute - Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Dallas VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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