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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGFuwai Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGFuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China
NOT_YET_RECRUITINGDevice success
(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).
Time frame: Perioperative period
30-day all-cause mortality
30-day all-cause mortality
Time frame: 30 days
30-day adverse aortic events
Aortic-related death, aortic dissection, or aortic rupture.
Time frame: 30 days
1-year all-cause mortality
1-year all-cause mortality
Time frame: 1 year
1-year cardiovascular mortality
1-year cardiovascular mortality
Time frame: 1 year
1-year adverse aortic events
Aortic-related death, aortic dissection, or aortic rupture.
Time frame: 1 year
Aortic expansion rate≥3mm/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.
Time frame: 1 year
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