A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 494
- Locations
- 47
- Primary Endpoint
- Number of Participants With Neurologic Injury
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
Detailed Description
The study will evaluate non-inferiority of neurologic injury incidence in a new cohort of subjects receiving improved blood pressure management to a control group (i.e., any FDA-approved LVAD for destination therapy). Secondary endpoints include: a comparison of stroke/TIA incidence to a reference observed in the original IDE clinical trial (HW004) that did not specify improved blood pressure management; and non-inferiority of stroke-free success on the originally implanted device to the control group. Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 60 months post-implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be ≥18 years of age at consent
- •Body Surface Area (BSA) ≥ 1.2 m2
- •Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following)a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or b. In Class III or Class IV heart failure for at least 14 days, and dependent on intra-aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days
- •Left ventricular ejection fraction ≤ 25%
- •LVAD implant is intended as destination therapy
- •Must be able to receive either the HeartWare® HVAD or control LVAD
- •Patient must agree to participate in and comply with an improved blood pressure management program, including maintenance of a patient diary.
- •Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- •The patient or legally authorized representative has signed the informed consent form
Exclusion Criteria
- •Body Mass Index (BMI) \> 40
- •Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
- •Prior cardiac transplant.
- •History of confirmed, untreated abdominal or thoracic aortic aneurysm \> 5 cm.
- •Cardiothoracic surgery within 30 days of randomization.
- •Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction ;.
- •Patients eligible for cardiac transplantation
- •On ventilator support for \> 72 hours within the four days immediately prior to randomization and implant.
- •Pulmonary embolus within three weeks of randomization as documented by computed tomography (CT) scan or nuclear scan.
- •Symptomatic cerebrovascular disease, stroke within 180 days of randomization or \> 80% stenosis of carotid or cranial vessels.
Outcomes
Primary Outcomes
Number of Participants With Neurologic Injury
Time Frame: Implant to 12 Months
The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) \> 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.
Secondary Outcomes
- Number of HeartWare VAS Participants With Stroke/TIA(Implant to 12 Months)
- Number of Participants With Stroke-Free Success(Implant to 12 Months)