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RecruitingNot ApplicableNCT06743568

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

Sponsor

China National Center for Cardiovascular Diseases

Enrollment

100 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic StenosisAscending Aortic Dilatation

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

Min Age: 65 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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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Interventions

DEVICETranscatheter aortic valve replacement

Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Locations(3)

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Fuwai Shenzhen Hospital

Shenzhen, Guangdong, China

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

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NCT06743568

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