On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

Running, not enrolling

Conditions studied: Thrombotic and Bleeding Events

In brief

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 facts

Study ID

NCT02677974

Run by

On-X Life Technologies, Inc.

People needed

510

Starts

2015-11-10

Expected to finish

2027-08-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve (ONXA, ONXAE, ONXAC, ONXACE, ONXAN, ONXANE) implant, without or without concomitant procedures, and agreed to participate in the registry.
• Life expectancy of at least 5 years.
• Patients whose operation occurred within the year prior to recruitment.

You may not qualify if…

• Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On-X mitral valve; i.e. no mitral or multiple valve implants.
• Patients with a prior history of arterial thromboembolic events, or who have such events or On-X valve thrombosis after AVR and prior to recruitment.
• Death prior to discharge or recruitment.
• Patients whose surgery predates enrollment by more than 1 year.

Where it is running

• 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

Full record on ClinicalTrials.gov

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