A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System for Destination Therapy of Advanced Heart Failure (ENDURANCE)
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|ClinicalTrials.gov Identifier: NCT01166347|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment|
|Chronic Heart Failure||Device: HeartWare® VAS Device: Control LVAD|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||451 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure|
|Study Start Date :||August 2010|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2017|
Experimental: HeartWare® VAS
Implant of HeartWare® Ventricular Assist System
Device: HeartWare® VAS
The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Active Comparator: Control LVAD
Implant of FDA-approved LVADs approved for destination therapy
Device: Control LVAD
Any FDA-approved LVAD for destination therapy.
- Stroke-free survival [ Time Frame: Two years ]The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.
- Incidence of bleeding [ Time Frame: Two years ]Incidence of bleeding, per INTERMACS definition
- Incidence of major infections [ Time Frame: Two years ]Incidence of major infections, per INTERMACS definition
- Incidence of all device failures and device malfunctions [ Time Frame: Two years ]Incidence of all device failures and device malfunctions per INTERMACS definition
- Time to death [ Time Frame: Two Years ]
- Health Status improvement measured by KCCQ and EuroQol EQ-5D [ Time Frame: Two Years ]Health Status improvement as measured by Kansas City Cardiomyopathy Questionaire (KCCQ) and EuroQol EQ-5D.
- Functional status improvement measured by (NYHA)class and 6-minute walk [ Time Frame: Two Years ]Functional status improvement, as measured by New York Heart Association (NYHA)class and 6-minute walk test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166347
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|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|