20 HVAD® Instructions for Use
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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
1.8 US Clinical Study: Destination Therapy
A. Study Design
well as some additional updated data from March 27, 2017, and included 451 subjects enrolled
at 48 investigational sites.
The trial was a prospective, randomized, controlled, multicenter clinical trial. Subjects were
randomly assigned using a permuted block, central randomization scheme, in a 2:1 ratio, to
receive either the study (HVAD) or control (HeartMate II) device.
The objective of the trial was to compare the safety and effectiveness of HVAD for destination
therapy to the HeartMate II, which is legally marketed in the U.S. for destination therapy, in
patients with end-stage heart failure who are ineligible for heart transplantation.
The sample size for formal hypothesis testing was to be determined adaptively. Subjects were to
be randomized until 450 subjects were randomized and implanted.
endpoint, the success rate from the control subjects would be assessed. If the observed control
observed control success was less than 55%, then no interim analysis would be performed and
the full 450 subjects would be subsequently analyzed. This adaptive sample size for statistical
analysis provides at least 90% power to establish non-inferiority.
Committee, which adjudicated all the adverse events according to the Interagency Registry
Data Safety Monitoring Board reviewed study compliance and monitored adverse events and
outcomes.
1. Clinical Inclusion and Exclusion Criteria
criteria:
-
and were transplant ineligible at the time of enrollment in whom informed consent was
obtained.
exclusion criteria:
- Patients eligible for cardiac transplant or with prior cardiac transplant.
- Patients with recent (within 14 days) acute myocardial infarction or stroke within 180
days.
- Patients with a mechanical heart valve.
- Patients with severe right heart failure in whom right ventricular support is anticipated.
- Patients who might be unwilling or unable to comply with the study criteria.
- Additional exclusion criteria available in the Clinical Study Report.
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