Clinical Trials

Inclusion Criteria:

- Heart Team agrees that the subject is deemed symptomatic and is a candidate for
transcatheter aortic valve replacement (TAVR)

- Subject has a predicted risk of operative mortality < 15% as determined by the local
Heart Team

- Subject has severe aortic stenosis as determined by transthoracic echocardiography
(TTE) at rest

- Subject has a small aortic annulus as determined by Multi-detector computed tomography
(MDCT)

- Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and Edwards
SAPIEN 3/3 Ultra TAV

- Subject's anatomy is suitable for TAVR via transfemoral vessel access

- Subject and the treating physician agree that the subject will return for all required
post-procedure follow-up visits

Exclusion Criteria:

- Estimated life expectancy of fewer 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 patients 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+/FX 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 the 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

- Previous aortic valve replacement

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/11/23. Questions regarding updates should be directed to the study team contact.