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

Heart Failure Clinical Trial

— COUNTER-HF  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01740596
• Other study ID #: PRO 03970-C
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2012
• Est. completion date: October 26, 2018

Study information

• Verified date: August 2023
• Source: Nuwellis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: October 26, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nuwellis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in 6 Minute Hall Walk (6MW) at 12-months	improvement of distance walked during the 6MW at 12-months.	12-months
Secondary	Improvement in LVEF at 12 Months.	Improvement in left ventricular ejection fraction (LVEF) at 12 months.	12-months
Secondary	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