TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

Conditions

• Bicuspid Aortic Valve Disease

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transcatheter Aortic Valve Replacement — PROCEDURE
  This is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
• the open chest surgery to replace the aortic valve — PROCEDURE
  This is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve

Study Details

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 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.

Key Dates

Start date

Jun 24, 2026

Status verified

Jan 2026

Primary completion

Jul 1, 2032

Completion

May 10, 2040

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Transcatheter Aortic Valve Replacement TAVR
  percutaneous approach as modality of treatment
• Active Comparator: Surgical Aortic Valve Replacement SAVR
  open chest approach as modality of treatment

Primary Outcome Measure

To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV [ Time Frame: 2 years post end of enrollment ]

Locations (1)

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