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COMPLETED NA

Prospective Randomized On-X Versus SJM Evaluation Trial

NCT00639782 · View on ClinicalTrials.gov ↗

Study Summary

The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.

Conditions Studied

Interventions

  • DEVICE On-X Heart valve replacement
  • DEVICE SJM Heart valve replacement

Study Locations (20)

Other

  • Universitats-Herzzentrum Bad Krozingen — Freiburg im Breisgau
  • Universitats-Herzzentrum Freiburg - Medical Center — Freiburg im Breisgau
  • Universitats Klinik Jena — Jena
  • Universitat Klinik Tübingen — Tübingen

British Columbia

  • St. Paul's Hospital — Vancouver
  • Vancouver General Hospital — Vancouver
  • Victoria Heart Institute — Victoria

Missouri

  • Washington University - St Louis — St Louis
  • Christian Hospital Northeast — St Louis

California

  • Southern California Permanente Medical Group — Los Angeles

Hawaii

  • Kaiser Foundation Hospital — Honolulu

New Jersey

  • Robert Wood Johnson Medical School — New Brunswick

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia

Virginia

  • Sentara Norfolk General Hospital — Norfolk

Trial Details

FieldValue
Enrollment Target 857 participants
Start Date 2003-07
Est. Completion 2021-05-01
Phase NA

Sponsor

On-X Life Technologies

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00639782

The ClinicalTrials.gov registry entry for NCT00639782 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 857 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is On-X Life Technologies, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Valve Disease appearing as the primary indexed condition, and to 2 interventions — of which On-X Heart valve replacement 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: NCT00639782 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, British Columbia, Missouri. 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 NCT00639782 about?

NCT00639782 is a clinical study titled "Prospective Randomized On-X Versus SJM Evaluation Trial". The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.

What is the current status of trial NCT00639782?

This trial is currently completed. It is a NA study. The enrollment target is 857 participants. The study started on 2003-07. Estimated completion is 2021-05-01.

What conditions does trial NCT00639782 study?

This clinical trial studies the following conditions: Heart Valve Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00639782?

The interventions under investigation include: On-X Heart valve replacement (DEVICE), SJM Heart valve replacement (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00639782?

This trial is sponsored by On-X Life Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00639782 being conducted?

This trial has 20 study locations across California, Hawaii, Missouri, New Jersey, Pennsylvania. 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