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NCT01452802 · ClinicalTrials.gov registry record
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
A clinical trial of Heart Failure, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 200
- Enrollment target
- 20
- Study locations
NCT01452802 is a study of Heart Failure that has completed, run by Abbott Medical Devices. The registered enrollment target is 200 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT01452802, a study of Heart Failure, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.
Conditions Studied
Interventions
- DEVICE HM II (HeartMate II LVAD)
- DRUG OMM (Optimal Medical Management)
Study Locations (20)
California
- Cedars Sinai Medical Center - Beverly Hills
- Keck Medical Center of USC - Los Angeles
- Sharp Memorial Hospital - San Diego
- Stanford University - Stanford
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
- University of Minnesota Medical Center - Minneapolis
- Mayo Clinic Rochester - Rochester
Florida
- Shands Hospital at University of Florida - Gainesville
- Tampa General Hospital - Tampa
Georgia
- Emory University Hospital - Atlanta
- St. Joseph's Hospital / Atlanta - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
- Advocate Christ Medical Center - Oak Lawn
Michigan
- Henry Ford Hospital - Detroit
- Michigan Heart - Ypsilanti
Arkansas
- Baptist Medical Center - Little Rock
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452802
The ClinicalTrials.gov registry entry for NCT01452802 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which HM II (HeartMate II LVAD) is the first listed.
NCT01452802 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Minnesota, Florida.
Frequently Asked Questions
What is clinical trial NCT01452802 about?
NCT01452802 is a clinical study titled "Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management". The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved ind...
What is the current status of trial NCT01452802?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2011-10. Estimated completion is 2016-06.
What conditions does trial NCT01452802 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT01452802?
The interventions under investigation include: HM II (HeartMate II LVAD) (DEVICE), OMM (Optimal Medical Management) (DRUG).
Who is sponsoring clinical trial NCT01452802?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01452802 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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