Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

NCT00121485 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 200 participants
Start Date 2005-02
Est. Completion 2012-01
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00121485 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Massachusetts, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00121485?

The interventions under investigation include: Left Ventricular Assist System (LVAS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00121485?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial