Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
ConditionBicuspid Aortic Valve (BAV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. There is still lack of consensus on the optimal sizing method for prosthesis selection in BAV patients.
The objective of the present study is to evaluate the efficacy and safety of the LIRA sizing method in raphe-type BAV patients undergoing TAVR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Redo-TAVR
TAVR performed in emergency setting
TAVR performed for severe aortic regurgitation
Trial population
All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: BAV patients underoging TAVR
Trial outcomes
Primary outcomes
1
Device success
Device success as defined by VARC 3 criteria : presence of technical success, freedom from mortality, freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complications, intended performance of the valve (less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25).
Time frame
Up to 30 days after TAVI procedureSecondary outcomes
1
Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria.
* All-cause mortality * All stroke * VARC type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury stage 3 or 4 * New permanent pacemaker due to procedure- related conduction abnormalities * Surgery or intervention related to the device
Time frame
Up to 30 days after TAVI procedure2
Clinical efficacy
Freedom from all-cause mortality, freedom from all stroke, freedom from hospitalization for procedure -or-valve-related causes, freedom from KCCQ Overall Summary score \<45 or decline from baseline \>10 point
Time frame
Up to 1 year after TAVI procedure3
Technical success
Freedom from mortality; successful access, delivery and retrieval of the delivery system; correct positioning of a single prosthetic heart valve into the proper anatomical location; freedom from surgey or intervention related to the device or to a major vascular or access-related, or cardiac structural.
Time frame
At exit from procedure room4
Intended performance of the valve
Less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25
Time frame
Up to 30 days after TAVI procedureSponsors and contacts
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Source ClinicalTrials.gov