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

NCT01740596 | Terminated Results DMC

• 1 other identifier: PRO 03970-C
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Heart Failure

Keywords

NYHA III; NYHA IV; ACC Stage C; Heart Failure; Congestive Heart Failure; C-Pulse; Counterpulsation; Heart Assist; Sunshine Heart; Left Heart Failure

Outcome Measures

Primary Outcomes (1)

• Primary Safety Outcome

  The primary safety endpoint is serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses.

  4 Years Follow-up

Secondary Outcomes (3)

• Improvement in 6 Minute Hall Walk (6MW) at 12-months

  12-months

• Improvement in LVEF at 12 Months.

  12-months

• Improvement in KCCQ Score at 12-months.

  12-months

Study Arms (2)

C-Pulse® System

EXPERIMENTAL

C-Pulse® System Counterpulsation

Device: C-Pulse® System Counterpulsation

Control Arm

NO INTERVENTION

Optimal Medical Therapy

Interventions

C-Pulse® System Counterpulsation DEVICE

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.

C-Pulse® System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Nuwellis, Inc.: lead

Study Sites (28)

The University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35249, United States

Location

University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

University of Miami Medical Center

Miami, Florida, 33136, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

University of Louisville - Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Mid America Heart Institute-Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Cornell University, New York - Presbyterian Hospital

New York, New York, 10065, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Charlotte-Mecklenburg Hospital - Carolinas Health Care System

Charlotte, North Carolina, 28203, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny-Singer Research Institute - Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Texas Heart Institute - St Luke's Hospital

Houston, Texas, 77030, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Audrey Singh
• Organization: CHF Solutions

audrey.singh@chf-solutions.com

9523454217

Study Officials

• William Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Margarita T Camacho, MD

  Newark Beth Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 4, 2012
• Study Start: September 12, 2012
• Primary Completion: September 19, 2018
• Study Completion: October 26, 2018
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2023-08

Locations

US (28)