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CoreValve Low Risk Study: Transcatheter Aortic Valve Replacement (TAVR) with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement

Research area:
Valve disease
Principal investigator:
Robert Stoler, MD, FACC, FSCAI
Type of study:
Interventional

Study synopsis:
This multi-center, prospective, single arm study evaluates the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR. Dallas location is the only Dallas area site with access for this trial.

Study objective:
This study evaluates the following outcomes measures:

  • All-cause mortality or disabling stroke rate at 30 days
  • Absence of procedural mortality AND
  • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
  • Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)
  • New permanent pacemaker implantation at 30 days
  • Life-threatening bleeding at 30 days, one year and annually through 10 years
  • Prosthetic valve endocarditis or prosthetic valve thrombosis at 30 days, one year and annually through 10 years
  • Valve-related dysfunction requiring repeat procedure at 30 days, one year, and annually through 10 years
  • Repeat hospitalization for aortic valve disease at 30 days, one year and annually through 10 years
  • Repeat hospitalization for ascending aorta disease at 30 days, one year and annually through 10 years
  • Hemodynamic performance metrics by Doppler echocardiography
  • New York Heart Association functional classification at baseline, 30 days, one year and annually through 5 years and at 7 years and 10 years
  • Health-related quality of life as assessed by Kansas City Cardiomyopathy Instrument and EQ-5D survey at specific time periods.
  • Baylor Scott & White Heart and Vascular Hospital – Dallas is the only site for this study in the Dallas/Fort Worth area.

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at: https://clinicaltrials.gov/ct2/show/NCT03635424
Study contact:
Emily Laible, Emily.Laible@BSWHealth.org, 214.820.9903.


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