Clinical trial NCT06743568: Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
Official title: Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Ascending Aortic Dilatation
Keywords: Transcatheter aortic valve replacement
Balloon-expandable valve
Self-expandable valve
Aortic stenosis
Ascending aortic dilation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a multi-center, open-label, two-arm randomized control trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Device success
timeFrame: Perioperative period
measure: 30-day all-cause mortality
timeFrame: 30 days
measure: 30-day adverse aortic events
timeFrame: 30 days
Secondary outcomes:
measure: 1-year all-cause mortality
timeFrame: 1 year
measure: 1-year cardiovascular mortality
timeFrame: 1 year
measure: 1-year adverse aortic events
timeFrame: 1 year
measure: Aortic expansion rate≥3mm/year
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
city: Shenzhen
country: China
facility: Fuwai Shenzhen Hospital
state: Guangdong
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
Study officials:
References: