C-Pulse® System: A Heart Assist Device Clinical Study
This trial is active, not recruiting.
|Treatment||c-pulse® system counterpulsation|
|Sponsor||Sunshine Heart Inc.|
|Start date||November 2012|
|End date||December 2017|
|Trial size||38 participants|
|Trial identifier||NCT01740596, PRO 03970-C|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||The University of Alabama at Birmingham Hospital||no longer recruiting|
|Los Angeles, CA||University of Southern California Keck School of Medicine||no longer recruiting|
|San Francisco, CA||University of California San Francisco||no longer recruiting|
|Clearwater, FL||Morton Plant Hospital||no longer recruiting|
|Hollywood, FL||Memorial Healthcare System||no longer recruiting|
|Miami, FL||University of Miami Medical Center||no longer recruiting|
|Macon, GA||Medical Center of Central Georgia||no longer recruiting|
|Louisville, KY||University of Louisville - Jewish Hospital||no longer recruiting|
|Houma, LA||Cardiovascular Institute of the South||no longer recruiting|
|New Orleans, LA||Ochsner Medical Center||no longer recruiting|
|Jackson, MS||University of Mississippi Medical Center||no longer recruiting|
|Kansas City, MO||Mid America Heart Institute-Saint Luke's Hospital||no longer recruiting|
|St. Louis, MO||St. Louis Heart and Vascular||no longer recruiting|
|Lincoln, NE||Nebraska Heart Institute||no longer recruiting|
|Newark, NJ||Newark Beth Israel Medical Center||no longer recruiting|
|New York, NY||Cornell University, New York - Presbyterian Hospital||no longer recruiting|
|Valhalla, NY||Westchester Medical Center||no longer recruiting|
|Charlotte, NC||Charlotte-Mecklenburg Hospital - Carolinas Health Care System||no longer recruiting|
|Columbus, OH||The Ohio State University Medical Center||no longer recruiting|
|Hershey, PA||Hershey Medical Center||no longer recruiting|
|Philadelphia, PA||Hospital of the University of Pennsylvania||no longer recruiting|
|Philadelphia, PA||Temple University||no longer recruiting|
|Pittsburgh, PA||Allegheny-Singer Research Institute - Allegheny General Hospital||no longer recruiting|
|Nashville, TN||Vanderbilt University Medical Center||no longer recruiting|
|Dallas, TX||Dallas VA Medical Center||no longer recruiting|
|Houston, TX||Texas Heart Institute - St Luke's Hospital||no longer recruiting|
|Richmond, VA||VCU Medical Center||no longer recruiting|
|Spokane, WA||Providence Sacred Heart Medical Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Efficacy Outcome Measure
time frame: 12 Month
Primary Safety Outcome
time frame: 12 Month
Male or female participants at least 18 years old.
- 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.
- 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
- Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study
- Patient demonstrates compliance issues that in the opinion of the investigator could interfere with the ability to manage the therapy (i.e. uncontrolled diabetes, mental health issues, etc.)
|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|
|Principal investigator||William Abraham, MD|
|Description||The C-Pulse® System is indicated for use in patients with moderate to severe heart failure while on optimal heart failure drug and on device therapies. The C-Pulse® System is intended to relieve the symptoms of heart failure, improve quality of life and cardiac function, and reduce the need for heart failure hospitalization. It is intended for use in hospital and at home. It is not intended as a replacement for heart function; it is not life sustaining or life-supporting therapy. It does not preclude the use of other heart failure therapies, such as valve surgery, heart transplantation or LVAD. 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. The non-blood contacting feature of the C-Pulse® System also allows the device to be intermittently turned off as tolerated. This allows the patient freedom for personal hygiene.|
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