An interventional study of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in Aortic Valve Stenosis and Bicuspid Aortic Valve, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review.
The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options.
The study patients will be followed with standard of care procedures for 10 years.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 250 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50% of patients will be treated with standard TAVR procedure and followed up for 10 years
Procedure: transcatheter aortic valve replacement (TAVR)
50% of patients will be treated with standard SAVR procedure and followed up for 10 years
Procedure: surgical aortic valve replacement (SAVR)
percutaneous transcatheter aortic valve replacement
surgical aortic valve replacement
1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)
The primary endpoint will be analyzed by the Win ratio method14. That is, every patient in the TAVR group will be compared with every patient in the SAVR group to determine which pair has won. A win higher up in the hierarchy takes priority, so KCCQ gets used only for those pairs that were tied on the first 5 event components. Then KCCQ win is declared if the time-averaged change in KCCQ differs by 5 points or more. The win ratio= total wins on TAVR divided by total wins on SAVR, for which a 95% CI and p value is calculated.
Time frame: 1 year
Technical success at time of exit from OR/cath lab
defined as meeting of the following: * Alive * Successful access, delivery and retrieval of the device delivery system * Deployment and correct positioning (including repositioning /recapture if needed) of the single intended valve * No additional unplanned or emergency surgery or re-intervention prior to leaving OR/Cath lab related to the device or access procedure (includes need for return to bypass post initial wean
Time frame: exit from procedure (OR or cath lab)
Device success
Defined as meeting all of the following: * Alive and stroke-free * Original intended device in place * No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR) * Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, or thrombosis 2. Hemodynamic performance: Mean gradient \< 20mmHg, AVA \>1cm2, jet velocity \< 3.0 m/s 3. Absence of the following para-device complications (PVL \> mild, erosion, hemolysis, or endocarditis)
Time frame: 30 days
Procedural success
Defined as meeting all of the following: 1. Life-threatening bleed (BARC 3b or greater) 2. Major vascular or cardiac structural complications requiring unplanned reintervention or surgery 3. Stage 2 or 3 AKI (includes new dialysis) 4. MI or need for PCI/CABG 5. Severe heart failure or hypotension requiring IV inotrope \>12 hours, ultrafiltration or mechanical circulatory support 6. Prolonged intubation \> 48 hours 7. Need for a permanent pacemaker implant or continuous, new onset atrial fibrillation
Time frame: 30 Days
Patient success
Defined as meeting all of the following: * Device success * No re-hospitalizations or re-interventions for the underlying condition (e.g., Aortic stenosis and Heart Failure) * Return to prior living arrangement (or equivalent) * Improvement in symptoms defined as increase in NYHA Class \> 1 compared to Baseline * Improvement in functional status defined as 6MWT \> 25 m compared to Baseline * Improvement in quality-of-life defined as KCCQ score \> 10 compared to Baseline
Time frame: 1 year
Plan to share: No
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