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

NCT02205411 | Terminated DMC

• 1 other identifier: CAP00030
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 14

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.

Conditions

Heart Failure; Cardiac Failure; Congestive Heart Failure; Heart Failure, Left-sided

Keywords

heart assist device; ventricular assist device

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is success at 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.

  180 days

Secondary Outcomes (4)

• Adverse Events

  180 days

• Quality of Life

  180 days

• Functional Status

  180 days

• Neurologic Status

  180 days

Study Arms (2)

HeartAssist 5® VAD System

EXPERIMENTAL

Implant of the HeartAssist 5® VAD System

Device: HeartAssist 5® VAD System

Control VAD

ACTIVE COMPARATOR

Device: Control VAD

Interventions

HeartAssist 5® VAD System DEVICE

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.

HeartAssist 5® VAD System

Control VAD DEVICE

The HeartMate II® VAD or HVAD®

Control VAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to sign Informed Consent.
• Age ≥ 18
• Body Surface Area (BSA) ≥ 1.2 m2.
• 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
• LVAD implantation has been approved by the institution's multidisciplinary transplant committee.
• Patient is NYHA Class IV.
• Able to return to the clinical site for all routine follow up visits.

You may not qualify if:

• Cardiothoracic surgery within 30 days prior to enrollment.
• Acute Myocardial Infarction within 14 days prior to enrollment.
• Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or left ventricular assist device.
• Mechanical, animal, or human tissue heart valve.
• History of untreated abdominal or thoracic aortic aneurysm \> 5 cm.
• On ventilator support for \> 72 hours within four days immediately prior to enrollment.
• Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).
• Proven history of pulmonary embolism within 90 days of enrollment.
• Moderate to severe aortic insufficiency as determined by echocardiogram without plans for correction during pump implantation surgery.
• Requires aortic, mitral, tricuspid or pulmonary valve replacements (including Bioprosthetic valves) or left ventricular (LV) aneurysm resection.
• 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)
• 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.
• Significant renal dysfunction defined as \> 3.5 mg/dl or requires hemo or peritoneal dialysis for renal failure (excluding ultra-filtration for fluid removal).
• 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.
• Pregnancy

Sponsors & Collaborators

• ReliantHeart Inc.: lead

Study Sites (14)

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Stanford

Stanford, California, 94305, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University Health, Inc. d/b/a Methodist Research Institute

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Hospital & Health Care Center

Indianapolis, Indiana, 46260, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic Hospital - Saint Mary's Campus

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

CHI St. Luke's Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Providence Sacred Heart Hospital

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 31, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-03

Locations

US (14)