Heart Valve DiseasePROACTNCT00291525

Randomized On-X Anticoagulation Trial

A study testing On-X valve using reduced anticoagulation and On-X Valve with Standard warfarin Therapy in people with Heart Valve Disease, run by On-X Life Technologies, Inc. at 49 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Heart Valve Disease
What is being tested?: On-X valve using reduced anticoagulation and On-X Valve with Standard warfarin Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 977 participants
Where: 49 sitesin 2 countries
Study dates: 6 Jun 2006to 29 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 14Show fewer

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

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

49 sites in 2 countries.

Country

City, postcode or hospital

49 sites in 2 countries

United States44 sites

New Mexico Heart Institute
Albuquerque, New Mexico, 87102
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48197
Emory University
Atlanta, Georgia, 30365
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University Hospital - Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
Baylor Research Institute
Dallas, Texas, 75226
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Mary Washington Hospital
Fredericksburg, Virginia, 22401
Shands Hospital - University of Florida
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06102
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Texas Heart Institute
Houston, Texas, 77225
St. Francis Heart Center
Indianapolis, Indiana, 46237
Mid America Heart institute
Kansas City, Missouri, 64111
Cardiac Surgical Associates
Kissimmee, Florida, 34741
University of Kentucky
Lexington, Kentucky, 40536
Loma Linda University
Loma Linda, California, 92354
Texas Cardiac Center
Lubbock, Texas, 79410
South Florida Heart & Lung
Miami, Florida, 33133
St. Luke's Aurora Health Care
Milwaukee, Wisconsin, 53215
West Virginia University
Morgantown, West Virginia, 26506
St. Luke's Roosevelt
New York, New York, 10025
Montefiore Medical Center
New York, New York, 10461
Christiana Health Care Services
Newark, Delaware, 19713
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
University of Oklahoma/VA Oklahoma City
Oklahoma City, Oklahoma, 73104
Florida Hospital
Orlando, Florida, 32803
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Baylor Scott & White - Plano
Plano, Texas, 78093
Maine Medical Center
Portland, Maine, 04102
Providence Heart & Vascular Institute
Portland, Oregon, 97220
WakeMed
Raleigh, North Carolina, 27610
Duke University Medical Center
Raleigh, North Carolina, 27710
Swedish Medical Center
Seattle, Washington, 98122
Barnes Jewish Hospital - Washington University
St Louis, Missouri, 63110
MultiCare Health System
Tacoma, Washington, 98415
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66604
Tucson Medical Center
Tucson, Arizona, 85718
Southern Arizona VA Medical Center
Tucson, Arizona, 85723
Medstar Heart & Vascular Institute
Washington D.C., District of Columbia, 20010
Novant Health
Winston-Salem, North Carolina, 27104

Other trials in United States

Canada5 sites

University of Alberta
Edmonton, Alberta, 76G 2B7
London Health Science Centre
London, Ontario, N6A 5A5
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
IUCPQ Chirurgie Cardiaque
Québec, Quebec, G1V 4G5
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

Read the detailed 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.

Conditions: Heart Valve Disease
Being tested: On-X valve using reduced anticoagulation, On-X Valve with Standard warfarin Therapy
Keywords: valve, prosthesis, antithrombotics, randomized
Medical subject headings: Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

On-X valve using reduced anticoagulationDevice
Also called On-X Prosthetic Heart Valve
Valve replacement with antiplatelet agents or lowered warfarin
On-X Valve with Standard warfarin TherapyDevice
Also called On-X Prosthetic Heart Valve
Valve replacement with standard dosage warfarin

Study groups in NCT00291525
Study group	Role	What they receive
AVR Low Risk without warfarin	Experimental	AVR Low Risk without warfarin Receives: Device: On-X valve using reduced anticoagulation
AVR low risk with standard warfarin	Active comparator	AVR low risk with standard warfarin Receives: Device: On-X Valve with Standard warfarin Therapy
AVR High risk with lower warfarin	Experimental	AVR High risk with lower warfarin Receives: Device: On-X valve using reduced anticoagulation
AVR High Risk with standard warfarin	Active comparator	AVR High Risk with standard warfarin Receives: Device: On-X Valve with Standard warfarin Therapy
MVR with lower warfarin	Experimental	MVR with lower warfarin Receives: Device: On-X valve using reduced anticoagulation
MVR with standard warfarin	Active comparator	MVR with standard warfarin Receives: Device: On-X Valve with Standard warfarin Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Thromboembolism
Percentage of events per patient year
Measured: 8 years
Valve Thrombosis
Percentage of events per patient year
Measured: 8 years
Bleeding Events
Percentage of events per patient year
Measured: 8 years

Secondary outcomes (2)

Valve-Related Mortality
Percentage of events per patient year
Measured: 8 years
Valve Hemodynamics
Echocardiograpic measures of valve hemodynamics at 5 years
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 200629 Dec 2023

First posted14 Feb 2006 (estimated)
Study start6 Jun 2006
Primary completion8 Aug 2023
Study completion29 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 977 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00291525
Sponsor's protocol ID: 2005-01
Other IDs: G050208
Acronym: PROACT
Status last verified: Oct 2024
First submitted: 10 Feb 2006
Last updated: 24 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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. No abstract available.
PubMed 30286937
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 prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.
PubMed 24512654
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.
PubMed 29504958
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 P, Duncan D, Yanagawa B, Ely J, Graeve A; PROACT Investigators. Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement. J Am Coll Cardiol. 2018 Jun 19;71(24):2717-2726. doi: 10.1016/j.jacc.2018.03.535.
PubMed 29903344
Ruel M, Chu MWA, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE, DeRose JJ, Lehr EJ, Alexander JH, Puskas JD; PROACT Mitral Investigators. Midterm survival, clinical, and hemodynamic outcomes of a novel mechanical mitral valve prosthesis. J Thorac Cardiovasc Surg. 2025 Oct;170(4):1060-1068.e3. doi: 10.1016/j.jtcvs.2024.11.029. Epub 2024 Nov 29.
PubMed 39617318
Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE 3rd, DeRose JJ, Lehr EJ, Alexander JH, Puskas JD; PROACT Mitral Investigators. Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg. 2023 Apr;115(4):929-938. doi: 10.1016/j.athoracsur.2022.12.031. Epub 2023 Jan 4.
PubMed 36610532
Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE 3rd, DeRose JJ, Lehr EJ, Puskas JD; PROACT Mitral Investigators. WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial. Ann Thorac Surg. 2022 Jan 28:S0003-4975(22)00138-2. doi: 10.1016/j.athoracsur.2022.01.015. Online ahead of print.
PubMed 35101419

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Heart Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
ClinicalTrials.gov ID: NCT00291525
Acronym / sponsor ID: PROACT / 2005-01
Conditions: Heart Valve Disease
Keywords: valve, prosthesis, antithrombotics, randomized
Study type: Interventional
Recruitment status: Completed
Enrolment: 977 participants (actual)
Lead sponsor: On-X Life Technologies, Inc.Industry (pharma, biotech, devices)
Collaborators: Clinipace Worldwide, Acelis Connected Health, WCG IRB, Avania
Study start: 6 Jun 2006 (actual)
Primary completion: 8 Aug 2023 (actual)
Study completion: 29 Dec 2023 (actual)
First posted: 14 Feb 2006 (estimated)
Results: Posted 24 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
AVR Low Risk without warfarin	Experimental	Device: On-X valve using reduced anticoagulationAVR Low Risk without warfarin
AVR low risk with standard warfarin	Active comparator	Device: On-X Valve with Standard warfarin TherapyAVR low risk with standard warfarin
AVR High risk with lower warfarin	Experimental	Device: On-X valve using reduced anticoagulationAVR High risk with lower warfarin
AVR High Risk with standard warfarin	Active comparator	Device: On-X Valve with Standard warfarin TherapyAVR High Risk with standard warfarin
MVR with lower warfarin	Experimental	Device: On-X valve using reduced anticoagulationMVR with lower warfarin
MVR with standard warfarin	Active comparator	Device: On-X Valve with Standard warfarin TherapyMVR with standard warfarin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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:
Concomitant cardiac surgery is allowed
Adult patients

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
On-X valve using reduced anticoagulationAlso: On-X Prosthetic Heart ValveValve replacement with antiplatelet agents or lowered warfarin	Device	AVR High risk with lower warfarin, AVR Low Risk without warfarin, MVR with lower warfarin
On-X Valve with Standard warfarin TherapyAlso: On-X Prosthetic Heart ValveValve replacement with standard dosage warfarin	Device	AVR High Risk with standard warfarin, AVR low risk with standard warfarin, MVR with standard warfarin

Primary outcome

Thromboembolism
Time frame: 8 years
Percentage of events per patient year
Valve Thrombosis
Time frame: 8 years
Percentage of events per patient year
Bleeding Events
Time frame: 8 years
Percentage of events per patient year

2 secondary outcomes

Valve-Related Mortality
Time frame: 8 years
Valve Hemodynamics
Time frame: 5 years

Results and safety

Results posted to the registry on 24 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AVR Low Risk Without Warfarin	99	19
AVR Low Risk With Standard Warfarin	102	74
AVR High Risk With Lower Warfarin	185	81
AVR High Risk With Standard Warfarin	190	112
MVR With Lower Warfarin	201	132
MVR With Standard Warfarin	200	120

Primary outcome: Thromboembolism

Time frame: 8 years. Number. Unit: %/patient years

Measure	AVR Low Risk Without Warfarin n = 99	AVR Low Risk With Standard Warfarin n = 102	AVR High Risk With Lower Warfarin n = 185	AVR High Risk With Standard Warfarin n = 190	MVR With Lower Warfarin n = 201	MVR With Standard Warfarin n = 200
Value	4.86	0.29	2.43	1.74	2.48	2.08

Primary outcome: Valve Thrombosis

Time frame: 8 years. Number. Unit: %/patient years

Measure	AVR Low Risk Without Warfarin n = 99	AVR Low Risk With Standard Warfarin n = 102	AVR High Risk With Lower Warfarin n = 185	AVR High Risk With Standard Warfarin n = 190	MVR With Lower Warfarin n = 201	MVR With Standard Warfarin n = 200
Value	0.69	0.87	0.21	0.37	0.46	0.40

Population analysed: Numbers in parentheses are Linearized Occurrence Rates (LOR)

Primary outcome: Bleeding Events

Time frame: 8 years. Number. Unit: Linearized Occurrence Rates (LOR): %/pat

Measure	AVR Low Risk Without Warfarin n = 99	AVR Low Risk With Standard Warfarin n = 102	AVR High Risk With Lower Warfarin n = 185	AVR High Risk With Standard Warfarin n = 190	MVR With Lower Warfarin n = 201	MVR With Standard Warfarin n = 200
Value	3.82	3.49	2.86	7.43	9.63	10.01

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AVR Low Risk Without Warfarin	13 of 99 (13.1%)	0 of 0	5 of 99
AVR Low Risk With Standard Warfarin	13 of 102 (12.7%)	0 of 0	4 of 102
AVR High Risk With Lower Warfarin	38 of 185 (20.5%)	0 of 0	10 of 185
AVR High Risk With Standard Warfarin	43 of 190 (22.6%)	0 of 0	9 of 190
MVR With Lower Warfarin	94 of 201 (46.8%)	0 of 0	17 of 201
MVR With Standard Warfarin	89 of 200 (44.5%)	0 of 0	23 of 200

Limitations and caveats (from the sponsor): 1. Study collected/reported events based on AATS/STS Guidelines (events of interest, with no serious/non-serious distinction). 2. Enrollment started 2006 for 3 arms: AVR Low Risk - Enrollment \& follow-up terminated 2014, indication not pursued AVR High Risk - Enrollment ended 2009, follow up completed 2014, low INR indication granted MVR - Enrollment ended 2020, follow up completed 2023, indication not pursued 3. Total SAEs is total of all categories presented minus mortality

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30286937Puskas 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. No abstract available.
Results publication: PubMed 24512654Puskas 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 prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.
Results publication: PubMed 29504958Yanagawa 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.
Results publication: PubMed 29903344Puskas 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 P, Duncan D, Yanagawa B, Ely J, Graeve A; PROACT Investigators. Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement. J Am Coll Cardiol. 2018 Jun 19;71(24):2717-2726. doi: 10.1016/j.jacc.2018.03.535.
Derived from this study: PubMed 39617318Ruel M, Chu MWA, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE, DeRose JJ, Lehr EJ, Alexander JH, Puskas JD; PROACT Mitral Investigators. Midterm survival, clinical, and hemodynamic outcomes of a novel mechanical mitral valve prosthesis. J Thorac Cardiovasc Surg. 2025 Oct;170(4):1060-1068.e3. doi: 10.1016/j.jtcvs.2024.11.029. Epub 2024 Nov 29.
Derived from this study: PubMed 36610532Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE 3rd, DeRose JJ, Lehr EJ, Alexander JH, Puskas JD; PROACT Mitral Investigators. Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg. 2023 Apr;115(4):929-938. doi: 10.1016/j.athoracsur.2022.12.031. Epub 2023 Jan 4.
Derived from this study: PubMed 35101419Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE 3rd, DeRose JJ, Lehr EJ, Puskas JD; PROACT Mitral Investigators. WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial. Ann Thorac Surg. 2022 Jan 28:S0003-4975(22)00138-2. doi: 10.1016/j.athoracsur.2022.01.015. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Puskas, MD study director

MOUNT SINAI HOSPITAL

49 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thromboembolism (time frame: 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291525, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.