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

Sponsor

Nuwellis, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01740596

Collaborator

(none)

Enrollment

Locations

Arms

73.4

Actual Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: C-Pulse® System Counterpulsation	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 12, 2012

Actual Primary Completion Date :

Sep 19, 2018

Actual Study Completion Date :

Oct 26, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: C-Pulse® System

C-Pulse® System Counterpulsation

Device: C-Pulse® System Counterpulsation

No Intervention: Control Arm

Optimal Medical Therapy

Outcome Measures

Primary Outcome Measures

Efficacy Outcome Measure [12 Month]
Evaluate the efficacy of the C-Pulse therapy by measuring freedom from worsening heart failure resulting in hospitalization, LVAD implantation, cardiac transplantation or death as compared to OMT.
Primary Safety Outcome [12 Month]
The primary safety endpoint is all serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses will be tested. All serious device and procedure related adverse events will be reported by number of event and number and proportion of subjects with event along with the ninety-five percent binomial exact confidence limits about the proportion of subjects with event. The serious device and procedure related adverse events will also be summarized by type of event.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

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