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

RecruitingNAAges 65 Years - anyAllChina National Center for Cardiovascular Diseases
NCT06743568 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transcatheter aortic valve replacement
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Where

3 sites
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China
Fuwai Shenzhen Hospital
Shenzhen, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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