Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter aortic valve replacement.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis, Ascending Aortic Dilatation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Transcatheter aortic valve replacement
Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.
Primary outcome measures
- Device success [Time frame: Perioperative period]
- 30-day all-cause mortality [Time frame: 30 days]
- 30-day adverse aortic events [Time frame: 30 days]
Secondary outcome measures (4)
- 1-year all-cause mortality [Time frame: 1 year]
- 1-year cardiovascular mortality [Time frame: 1 year]
- 1-year adverse aortic events [Time frame: 1 year]
- Aortic expansion rate≥3mm/year [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Med — Beijing
- Fuwai Shenzhen Hospital — Shenzhen
- Fuwai Yunnan Cardiovascular Hospital — Kunming
Identifiers
NCT: NCT06743568 · 2024-2486