C-Pulse® System: A Heart Assist Device Clinical Study (COUNTER-HF)

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: C-Pulse® System Counterpulsation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Left ventricular ejection fraction (LVEF) ≤ 35% (by transthoracic ECHO within 90 days prior to randomization)
2. ACC/AHA Stage C and NYHA III to ambulatory Class IV
3. Age ≥ 18 years
4. Must have cardiac resynchronization therapy (CRT) when clinically indicated, implanted ≥90 days prior to randomization.

5. 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.

6. 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.
7. 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

8. 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
9. 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:

1. Any evidence, as assessed within 90 days prior to enrollment, of either:

   1. Ascending aortic calcification on posterior-anterior or lateral chest x-ray
   2. Calcific ascending aortic disease as detected by non-contrast CT scan
   3. Ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or repaired aortic coarctation OR
   4. Has had an ascending aortic composite graft or root replacement
2. 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
3. Inotrope dependence - inability to wean from inotropic therapy
4. ACC/AHA Stage D heart failure or non-ambulatory NYHA Class IV subject
5. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, diastolic heart failure or technically challenging congenital heart disease
6. Reversible cause of heart failure that may be remedied by conventional surgery or other intervention
7. Moderate to severe aortic insufficiency (≥ 2+)
8. ST elevation myocardial infarction (STEMI) within 30 days prior to randomization
9. Cardiac surgery within 90 days prior to randomization
10. Prior cardiac transplantation, left ventricular reduction surgery, passive restraint device or surgically implanted left ventricular assist device
11. Anticipated concomitant cardiac surgical procedure
12. Serum creatinine ≥ 2.5mg/dL or any form of dialysis within 30 days prior to randomization
13. 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
14. Patient has severe intrinsic pulmonary disease in judgment of the investigator
15. Body Mass Index (BMI) < 18 or > 45 kg/m2

16. Suspected or active systemic infection

    1. Within 14 days prior to randomization and
    2. Evidenced by positive culture, antibiotics for empiric treatment or elevated WBC > 12K and temperature >38o C
17. 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
18. Positive serum pregnancy test, for women of childbearing potential
19. Patient has a condition, other than heart failure, which would limit survival to less than 2 years
20. Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study
21. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-Pulse® System; C-Pulse® System Counterpulsation	Device: C-Pulse® System Counterpulsation; 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.
No Intervention: Control Arm; Optimal Medical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in 6 Minute Hall Walk (6MW) at 12-months	improvement of distance walked during the 6MW at 12-months.	12-months
Improvement in LVEF at 12 Months.	Improvement in left ventricular ejection fraction (LVEF) at 12 months.	12-months
Improvement in KCCQ Score at 12-months.	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a quality-of-life assessment for heart failure patients taking into consideration severity of heart failure symptoms and limitations patients experience. The scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent	12-months

Collaborators and Investigators

• Sponsor: Nuwellis, Inc.
• Investigators: Principal Investigator: Margarita T Camacho, MD, Newark Beth Israel; Principal Investigator: William Abraham, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2012
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): October 26, 2018

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimated): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Congestive Heart Failure; Counterpulsation; NYHA III; NYHA IV; ACC Stage C; C-Pulse; Heart Assist; Sunshine Heart; Left Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PRO 03970-C