Heart Failure Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

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.

Exclusion Criteria:

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.)

Study is for people with:

Heart Failure

Estimated Enrollment:

38

Study ID:

NCT01740596

Recruitment Status:

Terminated

Sponsor:

Nuwellis, Inc.

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There are 28 Locations for this study

See Locations Near You

The University of Alabama at Birmingham Hospital
Birmingham Alabama, 35249, United States
University of Southern California Keck School of Medicine
Los Angeles California, 90033, United States
University of California San Francisco
San Francisco California, 94143, United States
Morton Plant Hospital
Clearwater Florida, 33756, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
University of Miami Medical Center
Miami Florida, 33136, United States
Medical Center of Central Georgia
Macon Georgia, 31201, United States
University of Louisville - Jewish Hospital
Louisville Kentucky, 40202, United States
Cardiovascular Institute of the South
Houma Louisiana, 70360, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Mid America Heart Institute-Saint Luke's Hospital
Kansas City Missouri, 64111, United States
St. Louis Heart and Vascular
Saint Louis Missouri, 63136, United States
Nebraska Heart Institute
Lincoln Nebraska, 68526, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Cornell University, New York - Presbyterian Hospital
New York New York, 10065, United States
Westchester Medical Center
Valhalla New York, 10595, United States
Charlotte-Mecklenburg Hospital - Carolinas Health Care System
Charlotte North Carolina, 28203, United States
The Ohio State University Medical Center
Columbus Ohio, 43210, United States
Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Temple University
Philadelphia Pennsylvania, 19140, United States
Allegheny-Singer Research Institute - Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Dallas VA Medical Center
Dallas Texas, 75216, United States
Texas Heart Institute - St Luke's Hospital
Houston Texas, 77030, United States
VCU Medical Center
Richmond Virginia, 23298, United States
Providence Sacred Heart Medical Center
Spokane Washington, 99204, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

38

Study ID:

NCT01740596

Recruitment Status:

Terminated

Sponsor:


Nuwellis, Inc.

How clear is this clinincal trial information?

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