TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

NCT07413965 | Not Yet Recruiting DMC

• 1 other identifier: BAV2025-4770
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bicuspid Aortic Valve Disease

Keywords

Severe Bicuspid Aortic Valve intervention: TAVR vs SAVR

Outcome Measures

Primary Outcomes (1)

• To compare the safety and efficacy of TAVR vs SAVR for the treatment of severe AS in patients with BAV

  A hierarchical composite (assessed by Win ratio at latest available follow-up) of: 1. death, 2. disabling stroke, 3. non-disabling stroke, 4. valve reintervention, 5. rehospitalization†, 6. unfavorable KCCQ (VARC-3\*)

  2 years post end of enrollment

Secondary Outcomes (10)

• Time-averaged KCCQ

  3 years post end of enrollment

• KCCQ status (serial)

  at 2 years post end of enrollment

• SF-12 questionnaire

  at 2 years post end of enrollment

• NYHA class

  at 2 years post end of enrollment

• 6-minute walk test

  at 2 years post end of enrollment

Study Arms (2)

Transcatheter Aortic Valve Replacement TAVR

OTHER

percutaneous approach as modality of treatment

Procedure: Transcatheter Aortic Valve Replacement

Surgical Aortic Valve Replacement SAVR

ACTIVE COMPARATOR

open chest approach as modality of treatment

Procedure: the open chest surgery to replace the aortic valve

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

Transcatheter Aortic Valve Replacement TAVR

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

Surgical Aortic Valve Replacement SAVR

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at time of consent
• 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)
• Gated contrast CT available and suitable for core laboratory analysis;

You may not qualify if:

• 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 adjudicated by the patient selection committee
• 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
• 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).
• 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).
• Leukopenia (WBC \< 3000 cells/µL), anemia (Hgb \< 8 g/dL), Thrombocytopenia (Plt \< 50,000 cells/µL).
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of randomization
• Ventricular dysfunction with LVEF \< 25%
• Stroke or transient ischemic attack (TIA) within 90 days of randomization
• Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Raj Makkar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Marcio Diniz, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Vinod Thourani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The comparator groups are TAVR and SAVR in patients over the age of 50 presenting for a bioprosthesis for severe aortic stenosis and bicuspid aortic valve anatomy. TAVR has shown superiority over SAVR in tricuspid aortic valve (TAV) anatomy in a randomized clinical trial53. However, although TAVR and SAVR have been widely used for BAV, there is to date no randomized trial or even systematic propensity matched data comparing TAVR and SAVR in BAV. The treatments of TAVR and SAVR are standard of care treatments, but the selection of one or the other in bicuspid anatomy remains arbitrary, with no clear framework available for patients and their physicians.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 17, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): May 10, 2040
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

US (1)