Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

957848
Heart
Dr. Ashequl Islam
Baystate Medical Center 759 Chestnut Street, Springfield, MA 01199
The purpose of this study is to demonstrate that the safety and effectiveness of the Medtronic Transcatheter Aortic Valve Replacement (TAVR) system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to Surgical Aortic Valve Replacement (SAVR) in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.
  1. Inclusion: Subjects with defined symptomatic or asymptomatic, severe aortic stenosis with an indication for SAVR with a bioprosthesis whose predicted risk of mortality at 30 days is < 3%.
  2. Exclusion: Bicuspid aortic valve identified by echocardiography, Multiple Detector Computed Tomography (MDCT), or Magnetic Resonance Imaging (MRI); Significant ascending aortopathy.
Annette Scarnici, RN
413-794-9076