Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Device success
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Self-expandable valve group
Patients who undergo transcatheter aortic valve replacement using self-expandable valves
Intervention: Transcatheter aortic valve replacement (Device)
Balloon-expandable valve group
Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves
Intervention: Transcatheter aortic valve replacement (Device)
Outcomes
Primary Outcomes
Device success
Time Frame: 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
Time Frame: 30 days
30-day all-cause mortality
30-day adverse aortic events
Time Frame: 30 days
Aortic-related death, aortic dissection, or aortic rupture.
Secondary Outcomes
- 1-year all-cause mortality(1 year)
- 1-year cardiovascular mortality(1 year)
- 1-year adverse aortic events(1 year)
- Aortic expansion rate≥3mm/year(1 year)