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Recruiting NCT06817148

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

No phase Interventional Aortic Valve Stenosis Bicuspid Aortic Valve

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR).
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis, Bicuspid Aortic Valve. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial

Overview

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.

Interventions

  • Procedure transcatheter aortic valve replacement (TAVR)
    percutaneous transcatheter aortic valve replacement
  • Procedure surgical aortic valve replacement (SAVR)
    surgical aortic valve replacement

Primary outcome measures

  • 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3) [Time frame: 1 year]
Secondary outcome measures (4)
  • Technical success at time of exit from OR/cath lab [Time frame: exit from procedure (OR or cath lab)]
  • Device success [Time frame: 30 days]
  • Procedural success [Time frame: 30 Days]
  • Patient success [Time frame: 1 year]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cedars-Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT06817148 · STUDY00003805

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗