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NCT02677974 · ClinicalTrials.gov registry record
On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
A clinical trial of Thrombotic and Bleeding Events, sponsored by On-X Life Technologies.
- Active
- Registry status
- 510
- Enrollment target
- 20
- Study locations
NCT02677974: Active study of Thrombotic and Bleeding Events, sponsored by On-X Life Technologies.
NCT02677974 is a study of Thrombotic and Bleeding Events that is active but no longer recruiting, run by On-X Life Technologies. The registered enrollment target is 510 participants. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02677974, a study of Thrombotic and Bleeding Events, is active but no longer recruiting, sponsored by On-X Life Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- 510 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).
Primary Outcome
Rates of occurrence for thromboembolism and/or thrombosis
Conditions Studied
Interventions
- DEVICE On-X Aortic Heart Valve replacement
Study Locations (20)
Texas
- University of Texas Southwestern - Dallas
- University of Texas Health Science Center - Houston - Houston
- Baylor Scott & White - Plano - Plano
Ohio
- The Lindner Center at The Christ Hospital - Cincinnati
- Cleveland Clinic - Cleveland
Virginia
- Sentara Norfolk General Hospital - Norfolk
- Carilion Clinic - Roanoke
Washington
- Swedish Medical Center - Seattle
- MultiCare Health System - Tacoma
Other
- Blackpool Victoria Hospital - Blackpool
- Hull & East Yorkshire Hospitals - Hull
Arizona
- Arizona Cardiothoracic & Neurology - Tucson
Connecticut
- Hartford Hospital - Hartford
Indiana
- Franciscan St. Francis - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2015-11-10 |
| Est. Completion | 2027-08 |
What the registry record for NCT02677974 still lists
NCT02677974 is an observational study that tracks outcomes without assigning an intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Thrombotic and Bleeding Events appearing as the primary indexed condition, and to 1 intervention - of which On-X Aortic Heart Valve replacement is the first listed.
NCT02677974 names 20 study sites across 14 states, led by Texas, Ohio, Virginia.
Frequently Asked Questions
What is clinical trial NCT02677974 about?
NCT02677974 is a clinical study titled "On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study". The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The object...
What is the current status of trial NCT02677974?
This trial is currently active not recruiting. The enrollment target is 510 participants. The study started on 2015-11-10. Estimated completion is 2027-08.
What conditions does trial NCT02677974 study?
This clinical trial studies the following conditions: Thrombotic and Bleeding Events.
What interventions are being tested in trial NCT02677974?
The interventions under investigation include: On-X Aortic Heart Valve replacement (DEVICE).
Who is sponsoring clinical trial NCT02677974?
This trial is sponsored by On-X Life Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02677974 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Indiana, Maine, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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