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

NCT02677974 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2015-01
• Study Type: observational
• Target: 510
• Locations: 3 countries
• Sites: 23

Brief 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).

Conditions

Thrombotic and Bleeding Events

Outcome Measures

Primary Outcomes (2)

• Thrombotic events

  Rates of occurrence for thromboembolism and/or thrombosis

  5 years

• Major bleeds

  Event rates for major bleeds

  5 years

Secondary Outcomes (1)

• Death

  5 years

Study Arms (1)

On-X Aortic Heart Valve replacement

Patients with On-X Aortic Valve maintained on low dose warfarin anticoagulation with an INR target of 1.5 to 2.0, with or without home monitoring.

Device: On-X Aortic Heart Valve replacement

Interventions

On-X Aortic Heart Valve replacement DEVICE

Aortic valve replacement with low dose warfarin

On-X Aortic Heart Valve replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with On-X aortic heart valve replacements implanted within the prior year.

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.

Sponsors & Collaborators

• On-X Life Technologies, Inc.: lead
• North American Science Associates Inc.: collaborator

Study Sites (23)

Arizona Cardiothoracic & Neurology

Tucson, Arizona, 85718, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Franciscan St. Francis

Indianapolis, Indiana, 46237, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58122, United States

Location

The Lindner Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Providence St. Vincent

Portland, Oregon, 97213, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

Baylor Scott & White - Plano

Plano, Texas, 75093, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

Victoria Heart Institute

Victoria, British Columbia, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

Hull & East Yorkshire Hospitals

Hull, United Kingdom

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Oo AY, Loubani M, Gerdisch MW, Zacharias J, Tsang GM, Perchinsky MJ, Hagberg RC, Joseph M, Sathyamoorthy M. On-X aortic valve replacement patients treated with low-dose warfarin and low-dose aspirin. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae117. doi: 10.1093/ejcts/ezae117.

  PMID: 38621698 BACKGROUND

• Gerdisch MW, Hagberg RC, Perchinsky MJ, Joseph M, Oo AY, Loubani M, Tsang GM, Zacharias J, Sathyamoorthy M. Low-dose warfarin with a novel mechanical aortic valve: Interim registry results at 5-year follow-up. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1645-1655.e6. doi: 10.1016/j.jtcvs.2024.04.017. Epub 2024 Apr 28.

  PMID: 38688451 BACKGROUND

Study Officials

• Goeff Tsang, MBChB

  Southampton University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: November 10, 2015
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (15); GB (5)