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Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation

RECRUITINGN/ASponsored by China National Center for Cardiovascular Diseases
Actively Recruiting
PhaseN/A
SponsorChina National Center for Cardiovascular Diseases
Started2024-10-15
Est. completion2026-07-31
Eligibility
Age65 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06743568

Summary

This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.

Eligibility

Age: 65 Years+Healthy volunteers accepted
Inclusion Criteria:

* Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less;
* Evaluation and selection for TAVR by the multidisciplinary heart team;
* Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan
* Anatomic suitability for a transfemoral vascular access;
* Life expectancy of more than 12 months;
* Age ≥65 years.

Exclusion Criteria:

* Pure aortic regurgitation;
* History of surgical or transcatheter aortic valve replacement (valve in valve);
* History of any aortic surgery;
* Emergent surgery;
* Patients who refused to be randomized or unable to complete regular follow-up.

Conditions3

Aortic StenosisAscending Aortic DilatationHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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