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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02677974
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
On-X Life Technologies, Inc.

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).

Condition or disease Intervention/treatment
Thrombotic and Bleeding Events Device: On-X Aortic Heart Valve replacement

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 510 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
Actual Study Start Date : November 10, 2015
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Aortic valve replacement with low dose warfarin




Primary Outcome Measures :
  1. Thrombotic events [ Time Frame: 5 years ]
    Rates of occurrence for thromboembolism and/or thrombosis

  2. Major bleeds [ Time Frame: 5 years ]
    Event rates for major bleeds


Secondary Outcome Measures :
  1. Death [ Time Frame: 5 years ]
    All cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with On-X aortic heart valve replacements implanted within the prior year.
Criteria

Inclusion Criteria:

  1. Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677974


Contacts
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Contact: Stephen E Ottmers, PhD 512-580-2254 Ottmers.Stephen@cryolife.com
Contact: Gretchen Wilderspin, MS 678-290-4309 Wilderspin.Gretchen@cryolife.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
On-X Life Technologies, Inc.
Investigators
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Study Director: Goeff Tsang, MBChB Southampton University
Additional Information:

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Responsible Party: On-X Life Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02677974    
Other Study ID Numbers: 2015-01
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes