Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis.
Kentaro Hayashida, Erik Bouvier, Thierry Lefèvre...
https://pubmed.ncbi.nlm.nih.gov/23756698Actively Recruiting
Age: 18Years +
All Genders
ID06657911
SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Led by IRCCS San Raffaele · Updated on 2025-01-03
250
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with raphe-type bicuspid aortic valve (BAV) who undergo transcatheter aortic valve replacement (TAVR). The study aims to evaluate the effectiveness and safety of a new sizing method called the LIRA method, designed to improve prosthesis selection for these patients. BAV patients have unique anatomy that challenges treatment, and previous data shows risks like stroke and permanent pacemaker implantation remain significant despite newer devices. The study involves patients with severe aortic stenosis and type 1 or 2 BAV who receive TAVR using self-expanding supra-annular prostheses sized by the LIRA method. This sizing approach measures the perimeter at the raphe level, where valve anchoring occurs in BAV patients. The study observes outcomes after TAVR, including device success, adverse events, clinical efficacy, technical success, and valve performance. Participants are evaluated up to 30 days and one year after the TAVR procedure to monitor device success and related adverse events according to VARC 3 criteria. Clinical efficacy and valve performance are also assessed during follow-up. The study collects data on technical success at the procedure's end and tracks any complications or outcomes related to the new sizing method, with the total study duration extending up to one year post-procedure.
CONDITIONS
Brief Title
Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Severe aortic stenosis with type 1 or 2 bicuspid aortic valve according to Sievers classification
- Undergoing transcatheter aortic valve replacement (TAVR) with self-expanding supra-annular prostheses sized by the LIRA method
- TAVR performed between September 2018 and June 2024
You will not qualify if you...
- Previous transcatheter aortic valve replacement (Redo-TAVR)
- Emergency TAVR procedures
- TAVR performed for severe aortic regurgitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 1 day
Participants undergo transcatheter aortic valve replacement (TAVR) with self-expanding supra-annular prostheses sized by the LIRA method.
1 procedure visit (in-person)
Follow-up
Duration - Up to 1 year after TAVR procedure
Participants are monitored for safety, device success, and clinical outcomes after the TAVR procedure.
Approximately 1 visit up to 30 days and additional assessments up to 1 year
Trial Site Locations
Total: 5 locations
1
Fondazione Poliambulanza
Brescia, Italy, Italy, 25100
Actively Recruiting
2
Spedali Civili
Brescia, Italy, Italy, 25100
Actively Recruiting
3
Ospedale San Donato
Milan, Italy, Italy, 20100
Actively Recruiting
4
San Camillo Hospital
Roma, Italy, Italy, 00100
Actively Recruiting
5
Luzerner Kantonsspital
Lucerne, Switzerland, Switzerland, 6009
Actively Recruiting
Loading map...
Research Team
P
Prof. Matteo Montorfano, MD
B
Barbara Bellini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry).
Timm Bauer, Axel Linke, Horst Sievert...
https://pubmed.ncbi.nlm.nih.gov/24342758Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study.
Gidon Y Perlman, Philipp Blanke, Danny Dvir...
https://pubmed.ncbi.nlm.nih.gov/27101906Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis.
Sung-Han Yoon, Thierry Lefèvre, Jung-Ming Ahn...
https://pubmed.ncbi.nlm.nih.gov/27609682A novel supra-annular plane to predict TAVI prosthesis anchoring in raphe-type bicuspid aortic valve disease: the LIRA plane.
Gianmarco Iannopollo, Vittorio Romano, Nicola Buzzatti...
https://pubmed.ncbi.nlm.nih.gov/31659989Supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease: the LIRA method.
Gianmarco Iannopollo, Vittorio Romano, Nicola Buzzatti...
https://pubmed.ncbi.nlm.nih.gov/32473284Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method.
Gianmarco Iannopollo, Vittorio Romano, Antonio Esposito...
https://pubmed.ncbi.nlm.nih.gov/35602251