Comparing self-expandable and balloon-expandable valves for aortic dilation treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of self-expandable versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement. Ascending aortic dilation is often seen in patients with aortic stenosis, particularly those with a bicuspid aortic valve. The trial is a multicenter, prospective randomized controlled design, focusing on patients with a maximum ascending aortic diameter of 45mm to 54mm. The goal is to clarify the impact of valve type on patient outcomes in this specific population.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting
• Fuwai Shenzhen Hospital
  Shenzhen, Guangdong, China Not yet recruiting
• Fuwai Yunnan Cardiovascular Hospital
  Kunming, Yunnan, China Not yet recruiting

Study contacts

• Study coordinator: Kang An, MD
• Email: ankang913@126.com
• Phone: +86-15801301740

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• TAVI without on-site heart surgery: can selected centers do it safely?

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.