Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT04722250
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04722250
Study Brief:
Protocol Section:
NCT04722250