RECRUITINGINTERVENTIONAL
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Transcatheter aortic valve replacement
Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.
Locations (3)
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Fuwai Shenzhen Hospital
Shenzhen, Guangdong, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China