Evaluating the LIRA method for sizing in patients with bicuspid aortic valves

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 observational study aims to assess the efficacy and safety of the LIRA sizing method for transcatheter aortic valve replacement (TAVR) in patients with raphe-type bicuspid aortic valves (BAV). The study will include patients over 18 years old with severe aortic stenosis and specific types of BAV who undergo TAVR with self-expanding supra-annular prostheses sized according to the LIRA method. The research addresses the challenges faced in treating BAV patients, particularly the high rates of complications associated with traditional sizing methods. By focusing on the unique anatomy of BAV, the study seeks to improve patient outcomes in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024

Exclusion Criteria:

* Redo-TAVR
* TAVR performed in emergency setting
* TAVR performed for severe aortic regurgitation

Where it's running

• Fondazione Poliambulanza
  Brescia, Italy, Italy Recruiting
• Spedali Civili
  Brescia, Italy, Italy Recruiting
• Ospedale San Donato
  Milan, Italy, Italy Recruiting
• San Camillo Hospital
  Roma, Italy, Italy Recruiting
• Luzerner Kantonsspital
  Lucerne, Switzerland, Switzerland Recruiting

Study contacts

• Principal investigator: Prof. Matteo Montorfano, MD — IRCCS San Raffaele Scientific Institute
• Study coordinator: Prof. Matteo Montorfano, MD
• Email: montorfano.matteo@hsr.it
• Phone: 0039/02/26437331

Similar studies

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

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• Sapien 3 TAVR for younger adults with aortic stenosis in China

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• Observing the progression of bicuspid aortic valve in Chinese patients

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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.