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Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation

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ClinicalTrials.gov Identifier: NCT02205411
Recruitment Status : Terminated (Inability to timely enroll.)
First Posted : July 31, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
ReliantHeart Inc.

Brief Summary:
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiac Failure Congestive Heart Failure Heart Failure, Left-sided Device: HeartAssist 5® VAD System Device: Control VAD Not Applicable

Detailed Description:

The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and will be compared to the HeartMate II and HVAD devices.

Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD System (treatment group) or control group (HeartMate II and HVAD). The physician will have the option to choose which control device to implant.

The primary objective of the study is to show non-inferiority of the HeartAssist 5® (treatment group) to the control group.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5® VAD System Compared to the Thoratec HeartMate II® VAD and HeartWare® HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation
Study Start Date : September 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HeartAssist 5® VAD System
Implant of the HeartAssist 5® VAD System
Device: HeartAssist 5® VAD System
The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.

Active Comparator: Control VAD Device: Control VAD
The HeartMate II® VAD or HVAD®




Primary Outcome Measures :
  1. The primary endpoint is success at 180 days [ Time Frame: 180 days ]
    Success at 180 days is defined as alive on the original device, transplanted or explanted for heart recovery and alive 60 days after device explant.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 180 days ]
    Device safety will be reported as the frequency of each adverse event, (including device failure, device malfunction or unanticipated adverse device effects) and the rate of adverse events per patient year.

  2. Quality of Life [ Time Frame: 180 days ]
    Quality of life data, as measured by the EuroQol (EQ-5D) will be summarized and analyzed, for both groups, comparing data at baseline and study intervals.

  3. Functional Status [ Time Frame: 180 days ]
    NYHA and six-minute walk analysis will be reported by group for data at pre-implant and at study-defined intervals.

  4. Neurologic Status [ Time Frame: 180 days ]
    Evaluation of any change in Modified Rankin Scale from baseline to 180-days post-implant or device explant.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to sign Informed Consent.
  2. Age ≥ 18
  3. Body Surface Area (BSA) ≥ 1.2 m2.
  4. Cardiac transplant candidate, defined as: Listed for cardiac transplant, and designated by the institution's multidisciplinary transplant committee as appropriate forLVAD Bridge-to-Transplantation therapy, or Designated by the institutions's multidisciplinary transplant committee as: 1) an appropriate candidate for LVAD Bridge-to transplant therapy, and 2) An inappropriate candidate for LVAD destination therapy
  5. LVAD implantation has been approved by the institution's multidisciplinary transplant committee.
  6. Patient is NYHA Class IV.
  7. Able to return to the clinical site for all routine follow up visits.

Exclusion Criteria:

  1. Cardiothoracic surgery within 30 days prior to enrollment.
  2. Acute Myocardial Infarction within 14 days prior to enrollment.
  3. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or left ventricular assist device.
  4. Mechanical, animal, or human tissue heart valve.
  5. History of untreated abdominal or thoracic aortic aneurysm > 5 cm.
  6. On ventilator support for > 72 hours within four days immediately prior to enrollment.
  7. Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).
  8. Proven history of pulmonary embolism within 90 days of enrollment.
  9. Moderate to severe aortic insufficiency as determined by echocardiogram without plans for correction during pump implantation surgery.
  10. Requires aortic, mitral, tricuspid or pulmonary valve replacements (including Bioprosthetic valves) or left ventricular (LV) aneurysm resection.
  11. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelets <100,000, INR > 1.6 or PTT > 2.5 times control in the absence of anticoagulation therapy)
  12. Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support OR extracorporeal membrane oxygenation (ECMO) at the time of implantation OR right atrial pressure > 20 mmHg while on multiple inotropes.
  13. Significant renal dysfunction defined as > 3.5 mg/dl or requires hemo or peritoneal dialysis for renal failure (excluding ultra-filtration for fluid removal).
  14. Evidence of intrinsic hepatic disease defined as liver enzyme values (AST, ALT and LDH that are > 3 times the upper limit of normal) OR a total bilirubin > 3 mg/dl OR biopsy proven liver cirrhosis or portal hypertension.
  15. Pregnancy
  16. Active systemic infection prior to study enrollment not yet resolved by treatment. Active Systemic Infection is defined by any one of the following in spite of antibiotic, antiviral or antifungal treatment: 2 or more consecutive positive cultures; elevated temperature > 37.2 (°C) and white blood cell count > 11.0 (103/ml); hypotension, tachycardia and generalized malaise.
  17. Stroke within 90 days prior to enrollment OR patient has a history of cerebral vascular disease with > 80% extra cranial stenosis documented by carotid Doppler study during transplant evaluation
  18. Modified Rankin Scale score of ≥ 2 or has any neurologic disability as confirmed by imaging (CT or MRI).
  19. Significant lower extremity peripheral vascular disease accompanied by rest pain or leg ulceration.
  20. Intolerant to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.
  21. Psychiatric disorder, or other psychosocial behavior that is likely to impair compliance with the study protocol.
  22. Receiving therapy with an investigational intervention or participating in any other clinical investigation at the time of enrollment.
  23. Condition, other than heart failure, that may limit survival to less than three (3) years and/or would exclude cardiac transplantation.
  24. Unwilling or unable to comply with any study requirement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205411


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
University of Stanford
Stanford, California, United States, 94305
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33146
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Health, Inc. d/b/a Methodist Research Institute
Indianapolis, Indiana, United States, 46202
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Mayo Clinic Hospital - Saint Mary's Campus
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
CHI St. Luke's Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Houston Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center
Houston, Texas, United States, 77030
United States, Washington
Providence Sacred Heart Hospital
Spokane, Washington, United States, 99204
Sponsors and Collaborators
ReliantHeart Inc.

Responsible Party: ReliantHeart Inc.
ClinicalTrials.gov Identifier: NCT02205411     History of Changes
Other Study ID Numbers: CAP00030
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: March 2018

Keywords provided by ReliantHeart Inc.:
heart assist device
ventricular assist device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases