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NCT00121485 · ClinicalTrials.gov registry record · NA
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
A NA study of Heart Failure, Congestive and Cardiomyopathies, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT00121485: Completed NA study of Heart Failure, Congestive and Cardiomyopathies, sponsored by Abbott Medical Devices.
NCT00121485 is a NA study of Heart Failure, Congestive and Cardiomyopathies that has completed, run by Abbott Medical Devices. The registered enrollment target is 200 participants, below the 670-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00121485, a NA study of Heart Failure, Congestive and Cardiomyopathies, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
Primary Outcome
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Conditions Studied
Interventions
- DEVICE Left Ventricular Assist System (LVAS)
Study Locations (20)
Massachusetts
- Tufts / New England Medical Center - Boston
- Massachusetts General Hospital - Boston
- Brigham & Women's Hospital - Boston
California
- Sharp Memorial Hospital - San Diego
- California Pacific Medical Center - San Francisco
Florida
- Shands Hospital @ University of Florida - Gainesville
- Tampa General Hospital - Tampa
Maryland
- University of Maryland School of Medicine - Baltimore
- Johns Hopkins Hospital - Baltimore
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic Hospital - Phoenix
Colorado
- University of Colorado Hospital - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2005-02 |
| Est. Completion | 2012-01 |
| Phase | NA |
What the finished NCT00121485 record still lists
NCT00121485 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 670-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Heart Failure, Congestive appearing as the primary indexed condition, and to 1 intervention - of which Left Ventricular Assist System (LVAS) is the first listed.
NCT00121485 names 20 study sites across 14 states, led by Massachusetts, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00121485 about?
NCT00121485 is a clinical study titled "Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy". The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approve...
What is the current status of trial NCT00121485?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2005-02. Estimated completion is 2012-01.
What conditions does trial NCT00121485 study?
This clinical trial studies the following conditions: Heart Failure, Congestive, Cardiomyopathies, Ventricular Dysfunction.
What interventions are being tested in trial NCT00121485?
The interventions under investigation include: Left Ventricular Assist System (LVAS) (DEVICE).
Who is sponsoring clinical trial NCT00121485?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00121485 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00121485's enrollment target sits among peer trials
200 18th of 39 higher than 22 of 39 other Heart Failure, Congestive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure, Congestive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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