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On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
Sponsor: On-X Life Technologies, Inc.
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
510
Start Date
2015-11-10
Completion Date
2027-08
Last Updated
2024-10-08
Healthy Volunteers
No
Conditions
Interventions
On-X Aortic Heart Valve replacement
Aortic valve replacement with low dose warfarin
Locations (23)
Arizona Cardiothoracic & Neurology
Tucson, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Franciscan St. Francis
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
Sanford Medical Center
Fargo, North Dakota, United States
The Lindner Center at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence St. Vincent
Portland, Oregon, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health Science Center - Houston
Houston, Texas, United States
Baylor Scott & White - Plano
Plano, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
MultiCare Health System
Tacoma, Washington, United States
University of Calgary
Calgary, Alberta, Canada
Victoria Heart Institute
Victoria, British Columbia, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Blackpool Victoria Hospital
Blackpool, United Kingdom
Hull & East Yorkshire Hospitals
Hull, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom