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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 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 636-participant average among 33 other Heart Failure, Congestive trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 14 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121485
The ClinicalTrials.gov registry entry for NCT00121485 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 636-participant average among 33 other Heart Failure, Congestive trials with a reported enrollment target (69% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.