An observational study in Bicuspid Aortic Valve (BAV), sponsored by IRCCS San Raffaele. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by IRCCS San Raffaele · Observational
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.
Bicuspid aortic valve (BAV) still represents a challenge for percutaneous treatment due to the peculiar anatomy.
BAV patients have been historically excluded from major randomized controlled trials.
Observational data have showed a high rate of paravalvular leak (PVL) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves.
More recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high.
These suboptimal results, possibly related to BAV different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting.
Recent evidence has shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, defined as the LIRA (Level of Implantation at the RAphe) plane. Thus, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level, the LIRA-method, has been developed in our center and validated in small cohorts of patients.
The aim of our study is to evaluate the efficacy and safety of the LIRA method in raphe-type bicuspid patients undergoing TAVR.
56 studies on the registry are indexed under Bicuspid Aortic Valve Disease; 24 are open to participants now.
This study's planned enrollment of 250 is close to the median of 245 across 36 observational studies indexed under Bicuspid Aortic Valve Disease.
Browse Bicuspid Aortic Valve Disease studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients with bicuspid aortic valve undergoing TAVI for severe aortic stenosis with sizing performed
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 procedure
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 procedure
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 procedure
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 room
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 procedure
Plan to share: No
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