BELIEVERS

What is the Purpose of this Study?

The novelty of the BELIEVERS trial lies in being the first adequately powered, randomized study to compare TAVR and SAVR with a bioprosthesis in BAV, incorporating imaging-guided stratification to optimize outcomes, incorporating robust patient-engagement approach in conduct and design addressing the critical gap in long-term outcomes for younger patients with BAV. It will be conducted in two phases. The feasibility phase will define clinical and anatomical risk profiles, refine imaging-guided patient selection, and optimize patient engagement. The full study phase will build on these findings to rigorously compare TAVR and SAVR in diverse patient subgroups, with long-term follow-up to assess durability, safety, and patient-centered outcomes.

Eligibility

1. 50 years of age or older at time of consent
2. Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)
3. Gated contrast CT available and suitable for core laboratory analysis;
4. BAV anatomy confirmed by CT core laboratory analysis

Inclusion Criteria:

1. 50 years of age or older at time of consent
2. Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)
3. Gated contrast CT available and suitable for core laboratory analysis;
4. BAV anatomy confirmed by CT core laboratory analysis

Exclusion Criteria:

1. Recent cardiovascular intervention within 30 days prior to randomization.
2. Presence of an existing TAVR or SAVR device
3. Pregnancy or lactation
4. Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review
5. Active enrollment in another investigational study
6. Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee
7. Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\<45mm but site plan for surgery of the aorta in the event of randomization to surgery
8. 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)
9. 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)
10. Plan to use any device other than commercially approved Edwards balloon expandable or Medtronic self-expanding TAVR
11. Leukopenia (WBC \< 3000 cells/µL), anemia (Hgb \< 8 g/dL), Thrombocytopenia (Plt \< 50,000 cells/µL) on latest available labs within 30 days prior to randomization
12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days prior to randomization
13. LVEF \< 25% within 90 days prior to randomization
14. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization
15. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula)
16. Severe lung disease (FEV1 \< 50% predicted), unresolved prior to randomization
17. History of liver disease defined as MELD Score ≥ 10 or Child-Pugh Class B or C
18. Unable to complete the KCCQ due cognitive impairment or other medical condition

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Bicuspid aortic valve replacement: EvaLuatIon of transcathetEr VERsus Surgery Trial

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Co-Investigators

Aakriti Gupta, Hasanian Al-Jilaihawi

Age Group

Adult

Phase

N/A

IRB Number

STUDY00004770

ClinicalTrials.gov ID

NCT07413965

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Email

clinicaltrials@cshs.org