Last updated on November 2017

Heart Valve Disease


Brief description of study

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).

Detailed Study 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.

Clinical Study Identifier: TX133772

Contact Investigators or Research Sites near you

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Jane Wernow

Shipley Cardiothoracic Center at HealthPark Medical Center
Fort Myers, FL USA
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