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

Last updated: December 17, 2024
Sponsor: China National Center for Cardiovascular Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Congestive Heart Failure

Treatment

Transcatheter aortic valve replacement

Clinical Study ID

NCT06743568
2024-2486
  • Ages > 65
  • All Genders

Study 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 Criteria

Inclusion

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 preoperativecontrast-enhanced computed tomography (CT) scan

  • Anatomic suitability for a transfemoral vascular access;

  • Life expectancy of more than 12 months;

  • Age ≥65 years.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Transcatheter aortic valve replacement
Phase:
Study Start date:
October 15, 2024
Estimated Completion Date:
July 31, 2027

Study Description

Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.

Connect with a study center

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

    Beijing, Beijing
    China

    Active - Recruiting

  • Fuwai Shenzhen Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan
    China

    Site Not Available

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