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NCT Number: NCT06657911

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

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.

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Key information

Conditions

Bicuspid Aortic Valve (BAV) Aortic Valve Disease Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Poliambulanza, Brescia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Device success

    Time frame: Up to 30 days after TAVI procedure

    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).

Secondary outcomes

  1. Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria.

    Time frame: Up to 30 days after TAVI procedure

    • 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

  2. Clinical efficacy

    Time frame: Up to 1 year after TAVI procedure

    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

  3. Technical success

    Time frame: At exit from procedure room

    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.

  4. Intended performance of the valve

    Time frame: Up to 30 days after TAVI procedure

    Less than moderate aortic regurgitation, mean gradient < 20 mmHg, peak velocity <3 m/s, doppler velocity index >0.25

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Bellini, MD

CONTACT

[email protected]

0039/02/26437331

Prof. Matteo Montorfano, MD

CONTACT

[email protected]

0039/02/26437331

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

Acronym: SUBLIME

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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