|Title||SURTAVI: Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement|
|Summary||The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.|
This randomized clinical study is to determine if replacing the aortic valve without open-heart surgery is as safe as or safer than open-heart surgery in patients with similar medical conditions as you.
The study valve is considered an “investigational device”, which means that clinical studies are required to determine if it is safe and provides clinical benefit.
Medtronic, Inc. is sponsoring this study to obtain data on the safety and performance of the investigational device. The Medtronic CoreValve® System and Medtronic CoreValve® Evolut R System includes the valves described below and two parts that help load and deliver the valves correctly.
|Inclusion/Notes||• Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is =3% and <15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;|
• Heart Team unanimously agree on treatment proposal and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
• Subject has severe aortic stenosis presenting with;
a. Critical aortic valve area defined as an initial aortic valve area of =1.0cm2 or aortic valve area index < 0.6cm2/m2 AND
b. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
• Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
|Principal Name||Richard Schwartz, MD|