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

NCT02677974 · tracked via the Priya Life Science UK tracker

Sponsor

On-X Life Technologies, Inc.

Phase

Observational

Started

2015-11-10

Last updated

2026-07-14

Condition(s) studied

Thrombotic and Bleeding Events

Investigational drug(s) / intervention(s)

On-X Aortic Heart Valve replacement

On-X Aortic Heart Valve replacement: Aortic valve replacement with low dose warfarin

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. 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. 2. Life expectancy of at least 5 years. 3. Patients whose operation occurred within the year prior to recruitment. Exclusion Criteria: 1. 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. 2. 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. 3. Death prior to discharge or recruitment. 4. Patients whose surgery predates enrollment by more than 1 year.

Primary outcome measure(s)

Thrombotic events — 5 years
Rates of occurrence for thromboembolism and/or thrombosis
Major bleeds — 5 years
Event rates for major bleeds

Trial sites (23)

Facility	City	Region
Arizona Cardiothoracic & Neurology	Tucson	Arizona
Hartford Hospital	Hartford	Connecticut
Franciscan St. Francis	Indianapolis	Indiana
Maine Medical Center	Portland	Maine
Sanford Medical Center	Fargo	North Dakota
The Lindner Center at The Christ Hospital	Cincinnati	Ohio
Cleveland Clinic	Cleveland	Ohio
Providence St. Vincent	Portland	Oregon
University of Texas Southwestern	Dallas	Texas
University of Texas Health Science Center - Houston	Houston	Texas
Baylor Scott & White - Plano	Plano	Texas
Sentara Norfolk General Hospital	Norfolk	Virginia
Carilion Clinic	Roanoke	Virginia
Swedish Medical Center	Seattle	Washington
MultiCare Health System	Tacoma	Washington
University of Calgary	Calgary	Alberta
Victoria Heart Institute	Victoria	British Columbia
University of Ottawa Heart Institute	Ottawa	Ontario
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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02677974 on ClinicalTrials.gov ↗ ← All trials in the UK