Heart Valve Disease – Aortic and Mitral

  • STATUS
    Recruiting
  • sponsor
    Medtronic
Updated on 5 February 2021
stenosis
aortic valve replacement

Summary

Study Description:

Multi-center, international, prospective, randomized, interventional, pre-market study. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.
Randomly assigned (50% to either group) Treatment of Aortic Stenosis with either Transcatheter Aortic Valve Replacement (TAVR) device or Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR).

Description

Eligibility Criteria:

Once you have decided to participate and have learned of the details of the trial you will be seen and evaluated for the following:
To be eligible to participate you will be evaluated for Severity of aortic stenosis. You must meet criteria for heart team agreement of low risk for Surgical Aortic Valve Replacement, where low risk is defined as predicted risk of mortality < 3% at 30 days.
Other criteria are required to be met based on measurements obtained from echocardiograms and computed tomography images.
Exclusions include specific anatomic characteristics of your diseased valve such as a bicuspid valve, additional surgical access exclusions and any condition considered a contraindication for placement of a bioprosthetic valve.

Other Details:

Participating in a study is a personal decision. You may wish to talk with family members or friends and your doctor before deciding to join a study. You or your doctor may contact the study research staff through the contacts provided on this page. Patients interested in participation in the trial are referred to our practice through a referring cardiologist.

Details
Condition Aortic Stenosis, Atrial Fibrillation, VALVULAR HEART DISEASE, Atrial Fibrillation (Pediatric), Heart Valve Disease
Clinical Study IdentifierTX133772
SponsorMedtronic
Last Modified on5 February 2021

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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