SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial


About this study

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

- 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mayra Guerrero, M.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information


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