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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sunshine Heart Inc.
Sponsor:
Information provided by (Responsible Party):
Sunshine Heart Inc.
ClinicalTrials.gov Identifier:
NCT01740596
First received: November 28, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Heart Failure
Device: C-Pulse® System Counterpulsation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sunshine Heart Inc.:

Primary Outcome Measures:
  • Efficacy Outcome Measure [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 388
Study Start Date: November 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740596

Locations
United States, Alabama
The University of Alabama at Birmingham Hospital Recruiting
Birmingham, Alabama, United States, 35249
Contact: Gina Horton, RN    205-975-8519      
Principal Investigator: Salpy V Pamboukian, MD         
United States, Georgia
Medical Center of Central Georgia Recruiting
Macon, Georgia, United States, 31201
Contact: Carrie Knott       knott.carrie@mccg.org   
Principal Investigator: Erskine A James, MD         
United States, Kentucky
University of Louisville - Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Terry Blanton, RN    502-587-4381    mtblan02@louisville.edu   
Principal Investigator: Mark Slaughter, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cristine Hardy       chardy@oschsner.org   
Principal Investigator: Umraan S Ahmad, MD         
United States, Massachusetts
Boston VA Medical Center Recruiting
Boston, Massachusetts, United States, 02130
Contact: Jennifer Gabany       Jennifer.gabany@va.gov   
Principal Investigator: Marco Zenati, MD         
United States, Missouri
Mid America Heart Institute-Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jackie Smith       jnsmith@saint-lukes.org   
Principal Investigator: Sanjeev Aggarwal, MD         
Washington University Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Tracy Sutton    314-747-1926    suttont@wudosis.wustl.edu   
Principal Investigator: Akinobut Itoh, MD         
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Lily Want, RN    973-926-8451    lwang@barnabashealth.org   
Principal Investigator: Margarita T Camacho, MD         
United States, New York
Cornell University, New York - Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Madeline Yushak       yushakm@nyp.org   
Principal Investigator: Evelyn Horn, MD         
United States, North Carolina
Charlotte-Mecklenburg Hospital - Carolinas Health Care System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Susan McClain, RN       susan.mcclain@carolinashealthcare.org   
Principal Investigator: Theodore Frank, MD         
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Shawna Oxier, RN    614-247-6797      
Principal Investigator: Rami Kahwash, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sean Johnson       sean.a.johnson@vanderbilt.edu   
Principal Investigator: Daniel Lenihan, MD         
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Anagha Phadke       anagha.phadke@va.gov   
Principal Investigator: Phi Wiegn, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Emily Taylor       etaylor2@houstonmethodist.org   
Principal Investigator: Jerry Estep         
United States, Virginia
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Stella Hamman       shamman@mcvh-vcu.edu   
Principal Investigator: Daniel Tang, MD         
United States, Washington
Providence Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Suzanne Anders       suzanne.anders@providence.org   
Contact: Jill Flatt       Jill.flatt@providence.org   
Principal Investigator: Nandini Nair, MD         
Sponsors and Collaborators
Sunshine Heart Inc.
Investigators
Principal Investigator: William Abraham, MD Ohio State University
Principal Investigator: Margarita T Camacho, MD Newark Beth Israel
  More Information

No publications provided

Responsible Party: Sunshine Heart Inc.
ClinicalTrials.gov Identifier: NCT01740596     History of Changes
Other Study ID Numbers: PRO 03970-C
Study First Received: November 28, 2012
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunshine Heart Inc.:
NYHA III
NYHA IV
ACC Stage C
Heart Failure
Congestive Heart Failure
C-Pulse
Counterpulsation
Heart Assist
Sunshine Heart
Left Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014