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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00291525
Other study ID # 2005-01
Secondary ID G050208
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 6, 2006
Est. completion date December 31, 2022

Study information

Verified date September 2022
Source On-X Life Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.


Description:

This is a longitudinal, randomized (randomization to occur at the 3-month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of up to 50 centers in the United States, Canada, and Italy enrolling and randomizing no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement, and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for up to 8 years in each patient. Each arm is independent and the low risk aortic and high risk aortic arms are completed. The low risk aortic arm was closed early resulting in a reduction of the estimated total enrollment with randomization to 1000. The high risk arm is completed with FDA review and this arm had 375 randomized enrollees. The mitral arm continues to enroll with a planned randomized enrollment of 400.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1200
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR). - AVR patients receiving low dose or antiplatelet only anticoagulation will be divided into groups at low risk and high risk for thromboembolism with all patients being in the low risk group except for patients with the following conditions which place a patient in the high risk group: - Chronic atrial fibrillation - Left ventricular ejection fraction < 30 % - Enlarged left atrium >50mm diameter - Spontaneous echo contrasts in the left atrium - Vascular pathology - Neurological events - Hypercoagulability - Left or right ventricular aneurysm - Lack of platelet response to aspirin or clopidogrel - Women receiving estrogen replacement therapy - Concomitant cardiac surgery is allowed - Adult patients Exclusion Criteria: - Right side valve replacement - Double (aortic plus mitral) valve replacement - Patients with active endocarditis at the time of implant - Previous confirmed or suspected thromboembolic event or thrombophlebitis - Other terminal illness - Patients who are in an emergency state - Inability to return for required follow-ups - Patients with an On-X valve implanted within the study and subsequently explanted - Patients who are known to be pregnant, plan to become pregnant or are lactating - Patients with acquired immunodeficiency syndrome or know to be HIV positive - Patients who are prison inmates or known drug or alcohol abusers - Patients unable to give adequate informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada London Health Science Centre London Ontario
Canada Ottawa Heart Institute Ottawa Ontario
Canada IUCPQ Chirurgie Cardiaque Quebec City Quebec
Canada University of British Columbia Vancouver British Columbia
United States New Mexico Heart Institute Albuquerque New Mexico
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham & Women's Hospital Boston Massachusetts
United States Cleveland Clinic Cleveland Ohio
United States University Hospital - Cleveland Cleveland Ohio
United States Ohio State University Medical Center Columbus Ohio
United States Baylor Research Institute Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Mary Washington Hospital Fredericksburg Virginia
United States Shands Hospital - University of Florida Gainesville Florida
United States Hartford Hospital Hartford Connecticut
United States Texas Heart Institute Houston Texas
United States University of Texas Health Science Center at Houston Houston Texas
United States St. Francis Heart Center Indianapolis Indiana
United States Mid America Heart institute Kansas City Missouri
United States Cardiac Surgical Associates Kissimmee Florida
United States University of Kentucky Lexington Kentucky
United States Loma Linda University Loma Linda California
United States Texas Cardiac Center Lubbock Texas
United States South Florida Heart & Lung Miami Florida
United States St. Luke's Aurora Health Care Milwaukee Wisconsin
United States West Virginia University Morgantown West Virginia
United States Montefiore Medical Center New York New York
United States St. Luke's Roosevelt New York New York
United States Christiana Health Care Services Newark Delaware
United States Sentara Norfolk General Hospital Norfolk Virginia
United States University of Oklahoma/VA Oklahoma City Oklahoma City Oklahoma
United States Florida Hospital Orlando Florida
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Baylor Scott & White - Plano Plano Texas
United States Maine Medical Center Portland Maine
United States Providence Heart & Vascular Institute Portland Oregon
United States Duke University Medical Center Raleigh North Carolina
United States WakeMed Raleigh North Carolina
United States Barnes Jewish Hospital - Washington University Saint Louis Missouri
United States Swedish Medical Center Seattle Washington
United States MultiCare Health System Tacoma Washington
United States Cotton-O'Neil Clinical Research Center Topeka Kansas
United States Southern Arizona VA Medical Center Tucson Arizona
United States Tucson Medical Center Tucson Arizona
United States Medstar Heart & Vascular Institute Washington District of Columbia
United States Novant Health Winston-Salem North Carolina

Sponsors (5)

Lead Sponsor Collaborator
On-X Life Technologies, Inc. Acelis Connected Health, Avania, Clinipace Worldwide, WCG IRB

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

Puskas J, Gerdisch M, Nichols D, Quinn R, Anderson C, Rhenman B, Fermin L, McGrath M, Kong B, Hughes C, Sethi G, Wait M, Martin T, Graeve A; PROACT Investigators. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the — View Citation

Puskas JD, Gerdisch M, Nichols D, Fermin L, Rhenman B, Kapoor D, Copeland J, Quinn R, Hughes GC, Azar H, McGrath M, Wait M, Kong B, Martin T, Douville EC, Meyer S, Ye J, Jamieson WRE, Landvater L, Hagberg R, Trotter T, Armitage J, Askew J, Accola K, Levy — View Citation

Puskas JD; PROACT Investigators. Reply: Low-Thrombogenicity Mechanical Heart Valves: Which Antithrombotic Strategy? J Am Coll Cardiol. 2018 Oct 9;72(15):1879-1880. doi: 10.1016/j.jacc.2018.07.063. — View Citation

Yanagawa B, Levitsky S, Puskas JD; PROACT Investigators. Reduced anticoagulation is safe in high-risk patients with the On-X mechanical aortic valve. Curr Opin Cardiol. 2015 Mar;30(2):140-145. doi: 10.1097/HCO.0000000000000149. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Thromboembolism Rate of thromboembolism evaluated every 100 patient-years 8 years
Primary Valve Thrombosis Rate of thrombosis evaluated every 100 patient-years 8 years
Primary Bleeding Events Rate of major and minor bleeding events evaluated every 100 patient-years 8 years
Secondary Valve-Related Events Rates of other valve-related events (e.g. prosthetic valve dysfunction, hemolysis, hemolytic anemia, endocarditis) every 100 patient-years 8 years
Secondary New York Heart Association (NYHA) classification Functional classification at each follow-up 8 years
Secondary Valve Hemodynamics Echocardiograpic measures of valve hemodynamics at 1, 3 and 5 years 5 years
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