VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
NCT00490321 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225
Last updated 2009-09-09
Summary
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.
This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
Conditions
- End-stage Heart Failure
- Cardiomyopathies
Interventions
- DEVICE
-
VentrAssistTM Left Ventricular Assist Device
Sponsors & Collaborators
-
International Center for Health Outcomes and Innovation Research
collaborator OTHER -
Ventracor
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Completion
- 2012-06-30
Countries
- United States
Study Locations
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