SMART – Tavr Trial: A Prospective Multicenter Randomized Trial To Evaluate The Hemodynamics And Valve Deterioration/Durability Of Medtronic Corevalve Vs. Edwards Sapien Valve In Patients With Small Aortic Annular Size

General Information Age Group Adults Status Active Protocol Number U21-04-4439 Background Information The purpose of this trial is to generate clinical evidence on valve safety and performace of self-expanding (SE) versus ballon-expandable (BE) Transcatheter Aortic Valve Replacement (Tavr) In subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Devices include medtronic evolut pro or evolut pro+ transcather aortic valve systems and edwards sapien 3 or sapien 3 ultra transcather heart valve systems. Offered At Inova Fairfax Medical Campus 3300 Gallows Road Falls Church, VA 22042 Inova Center for Personalized Health 8081 Innovation Park Drive, Suite 700 Fairfax, VA 22031 Virginia Heart Fairfax 2901 Telestar Court, Suite 200 Falls Church, VA 22042 Principal Investigator Matthew Sherwood, MD Eligibility Information Symptomatic subjects with predicted risk of operative mortality < 15% at 30 days per multidisciplinary Local Heart Team Assessment Severe aortic stenosis, defined as: aortic valve area ≤ 1.0 cm2 (or aortic valve area index of ≤ 0.6 cm2/M2), or mean gradient ≥ 40 mmhg, or maximal aortic valve velocity ≥ 4.0 m/sec by transthoracic echocardiography at rest Aortic valve annulus area ≤ 430 Mm2 based on MDCT Subject’s anatomy is appropriate for both Medtronic Evolut Pro/Pro+ Tav and Edwards Sapien 3/3 Ultra Tav Subject’s anatomy is suitable for Tavr via transfemoral vessel access Commercial indication for Transcatheter Aortic Valve Replacement (Tavr), in conformity with both local regulations and instructions for use (IFU) Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Ineligibility Information Estimated life expectancy of less than 2 years Multivessel coronary artery disease with a syntax score > 32 and/or unprotected left main coronary artery (syntax score calculation is not required for subjects with history of previous revascularization if repeat revascularization is not planned) Participating in another trial that may influence the outcome of this trial Need for an emergent procedure for any reason Contraindicated for treatment with the evolut pro/Pro+ and edwards sapien 3/3 ultra tav in accordance with the instructions for use Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams Pregnant, nursing or planning to be pregnant Subject is less than legal age of consent, legally incompetent, unable to provide his/her own Informed consent, or otherwise vulnerable Subject has an active COVID-19 infection or relevant history of COVID-19. Note: An active COVID-19 infection is defined as a positive polymerase chain reaction (PCR) Result. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19 that was less than 3 months prior to enrollment. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment Previous aortic valve replacement For additional information, please visit: https://www.clinicaltrials.gov/ct2/show/NCT04722250 Contact Information Contact Name Van Doan Contact Phone 703-776-8008 Contact Email Send Email