38 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
1.9 Destination Therapy Supplemental Study
A. Study Design
effectiveness of a prospective blood pressure management strategy in HVAD DT patients.
The purpose of implementing the prospective blood pressure management strategy was
to investigate its effect on the stroke rates in HVAD subjects. The trial was a prospective,
randomized, controlled, un-blinded, multicenter clinical study. 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. All HVAD subjects, in addition to receiving standard
of care management, were required to adhere to a blood pressure management protocol
method) or < 90 mmHg (Doppler cuff method). Control patients were not managed with a
blood pressure management protocol.
August 7, 2015. 475 subjects were randomized, with 465 patients implanted at 47 investigational
sites.
oversight of an independent Clinical Events Committee and monitored by an independent
Data Safety Monitoring Board.
1. Clinical Inclusion and Exclusion Criteria
2. Follow-up Schedule
All patients were scheduled to return for follow-up examinations at 3 and 6 months with a
and 60 months with a window of ± 14 days postoperatively.
3. Clinical Endpoints
spinal cord infarct (SCI).
The HVAD was to be considered non-inferior to the HeartMate II if the upper bound of the
between the HVAD arm and the control arm was less than 6%.
stroke and TIA by 12 months on the originally implanted HVAD. Unlike the primary endpoint,
post-stroke. This endpoint was to be tested by comparison to a performance goal of 17.7%;
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