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NCT Number: NCT06817148

Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial

The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review.

The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options.

The study patients will be followed with standard of care procedures for 10 years.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Bicuspid Aortic Valve 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 Ventricular Outflow Obstruction

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged > 50 years of age
  • Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
  • Gated contrast CT available and suitable for core laboratory analysis
  • BAV anatomy confirmed by CT core laboratory analysis

Exclusion criteria

  • Recent cardiovascular intervention within the prior 30 days.
  • Presence of an existing TAVR or SAVR device
  • Pregnancy or lactation
  • Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
  • Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
  • Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA<45 mm but site plan for surgery of the aorta in the event of randomization to surgery
  • Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)
  • In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG).

Treatment and study plan

transcatheter aortic valve replacement (TAVR)

Procedure

percutaneous transcatheter aortic valve replacement

surgical aortic valve replacement (SAVR)

Procedure

surgical aortic valve replacement

Primary outcomes

  1. 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)

    Time frame: 1 year

    The primary endpoint will be analyzed by the Win ratio method14. That is, every patient in the TAVR group will be compared with every patient in the SAVR group to determine which pair has won. A win higher up in the hierarchy takes priority, so KCCQ gets used only for those pairs that were tied on the first 5 event components. Then KCCQ win is declared if the time-averaged change in KCCQ differs by 5 points or more. The win ratio= total wins on TAVR divided by total wins on SAVR, for which a 95% CI and p value is calculated.

Secondary outcomes

  1. Technical success at time of exit from OR/cath lab

    Time frame: exit from procedure (OR or cath lab)

    defined as meeting of the following:

    • Alive
    • Successful access, delivery and retrieval of the device delivery system
    • Deployment and correct positioning (including repositioning

    /recapture if needed) of the single intended valve

    • No additional unplanned or emergency surgery or re-intervention prior to leaving OR/Cath lab related to the device or access procedure (includes need for return to bypass post initial wean

  2. Device success

    Time frame: 30 days

    Defined as meeting all of the following:

    • Alive and stroke-free
    • Original intended device in place
    • No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR)
    • Intended performance of the device:
    • Structural performance: No migration, embolization, detachment, fracture, or thrombosis
    • Hemodynamic performance: Mean gradient < 20mmHg, AVA >1cm2, jet velocity < 3.0 m/s
    • Absence of the following para-device complications (PVL > mild, erosion, hemolysis, or endocarditis)

  3. Procedural success

    Time frame: 30 Days

    Defined as meeting all of the following:

    • Life-threatening bleed (BARC 3b or greater)
    • Major vascular or cardiac structural complications requiring unplanned reintervention or surgery
    • Stage 2 or 3 AKI (includes new dialysis)
    • MI or need for PCI/CABG
    • Severe heart failure or hypotension requiring IV inotrope >12 hours, ultrafiltration or mechanical circulatory support
    • Prolonged intubation > 48 hours
    • Need for a permanent pacemaker implant or continuous, new onset atrial fibrillation

  4. Patient success

    Time frame: 1 year

    Defined as meeting all of the following:

    • Device success
    • No re-hospitalizations or re-interventions for the underlying condition (e.g., Aortic stenosis and Heart Failure)
    • Return to prior living arrangement (or equivalent)
    • Improvement in symptoms defined as increase in NYHA Class > 1 compared to Baseline
    • Improvement in functional status defined as 6MWT > 25 m compared to Baseline
    • Improvement in quality-of-life defined as KCCQ score > 10 compared to Baseline

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Acronym: BELIEVE-IT

Important dates

Study start
2025
Primary completion
2028
Study completion
2037
First posted
Feb 10, 2025
Registry last updated
Feb 10, 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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