At a glance
ClinicalIndex Comparison RecordN/ACompleted· 101 enrolled
Drug / intervention
HeartWare® VASdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
In Brief
An observational study evaluating HeartWare® VAS for Heart Failure. Completed, enrolled 101 participants across 25 sites.
Detailed Summary
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedApr 2013
Primary CompletionNov 2017
Study CompletionMar 2018
TodayJul 2026
First PostedApr 16, 2013
Enrollment StartJan 1, 2013
Primary CompletionNov 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 13.2 years ago
Interventions
HeartWare® VASdevice
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.