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NCT07413965

TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR). TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease.. SAVR is involving the open chest surgery to replace the aortic valve. The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA. Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure. Consented patients who will not qualify for the randomized part of the study they will be followed up clinically in either TAVR or SAVR Registry arms. The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.

Official title: Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-04-05

Completion Date

2040-05-10

Last Updated

2026-02-17

Healthy Volunteers

Conditions

Bicuspid Aortic Valve Disease

Interventions

PROCEDURE

Transcatheter Aortic Valve Replacement

This is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve

PROCEDURE

the open chest surgery to replace the aortic valve

This is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve

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; Exclusion Criteria: 1. Recent cardiovascular intervention within the prior 30 days. 2. Presence of an existing TAVR or SAVR device 3. Pregnancy or lactation 4. Extreme or prohibitive TAVR or SAVR risk, determined by site or committee 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. Pre-specified plan, if randomized to TAVR, for platform other than contemporary Edwards Sapien or Medtronic Evolut platform (platform must be stated prior to randomization). 11. Leukopenia (WBC \< 3000 cells/µL), anemia (Hgb \< 8 g/dL), Thrombocytopenia (Plt \< 50,000 cells/µL). 12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of randomization 13. Ventricular dysfunction with LVEF \< 25% 14. Stroke or transient ischemic attack (TIA) within 90 days of randomization 15. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) 16. Severe lung disease (FEV1 \< 50% predicted) 17. History of severe liver disease as determined by the case review committee

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States