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

Not Applicable

Recruiting

• Conditions: Aortic Stenosis; Ascending Aortic Dilatation

• Registration Number: NCT06743568
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-10-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Device success	Perioperative period	(1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
30-day all-cause mortality	30 days	30-day all-cause mortality
30-day adverse aortic events	30 days	Aortic-related death, aortic dissection, or aortic rupture.

Secondary Outcome Measures

Name	Time	Method
1-year cardiovascular mortality	1 year	1-year cardiovascular mortality
1-year adverse aortic events	1 year	Aortic-related death, aortic dissection, or aortic rupture.
1-year all-cause mortality	1 year	1-year all-cause mortality
Aortic expansion rate≥3mm/year	1 year	The aortic expansion rate was defined by the change of AA diameter (before the procedure and at the latest follow-up) divided by the follow-up period.

Trial Locations

Locations (3)

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

Fuwai Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Fuwai Yunnan Cardiovascular Hospital; 🇨🇳 Kunming, Yunnan, China