Clinical trial NCT02205411: Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Cardiac Failure
Congestive Heart Failure
Heart Failure, Left-sided
Keywords: heart assist device
ventricular assist device
Lead sponsor: ReliantHeart Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The primary endpoint is success at 180 days
timeFrame: 180 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 180 days
measure: Quality of Life
timeFrame: 180 days
measure: Functional Status
timeFrame: 180 days
measure: Neurologic Status
timeFrame: 180 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: University of Stanford
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health, Inc. d/b/a Methodist Research Institute
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital & Health Care Center
state: Indiana
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital - Saint Mary's Campus
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: CHI St. Luke's Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Spokane
country: United States
facility: Providence Sacred Heart Hospital
state: Washington
Study officials:
References: