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

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.

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

• 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

• 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