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

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis, Ascending Aortic Dilatation

In brief

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.

Key facts

Study ID

NCT06743568

Run by

China National Center for Cardiovascular Diseases

People needed

100

Starts

2024-10-15

Expected to finish

2027-07-31

Last updated by the study team

2024-12-20

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)
• Fuwai Shenzhen Hospital — Shenzhen, Guangdong, China
• Fuwai Yunnan Cardiovascular Hospital — Kunming, Yunnan, China

Full record on ClinicalTrials.gov

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