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TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

NCT07413965 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-05-12

No results posted yet for this study

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 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.

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

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    collaborator OTHER

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Raj Makkar, MD · Cedars-Sinai Medical Center

  • Marcio Diniz, PhD · Icahn School of Medicine at Mount Sinai

  • Vinod Thourani, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-24
Primary Completion
2032-07-01
Completion
2040-05-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413965 on ClinicalTrials.gov