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NCT06817148 · ClinicalTrials.gov registry record · NA
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
A NA study of Aortic Valve Stenosis and Bicuspid Aortic Valve, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT06817148 is a NA study of Aortic Valve Stenosis and Bicuspid Aortic Valve that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 250 participants, below the 1,035-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06817148, a NA study of Aortic Valve Stenosis and Bicuspid Aortic Valve, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE transcatheter aortic valve replacement (TAVR)
- PROCEDURE surgical aortic valve replacement (SAVR)
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-01-31 |
| Est. Completion | 2037-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06817148
The ClinicalTrials.gov registry entry for NCT06817148 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,035-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (76% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which transcatheter aortic valve replacement (TAVR) is the first listed.
NCT06817148 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06817148 about?
NCT06817148 is a clinical study titled "Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial". 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...
What is the current status of trial NCT06817148?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2025-01-31. Estimated completion is 2037-02-01.
What conditions does trial NCT06817148 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Bicuspid Aortic Valve.
What interventions are being tested in trial NCT06817148?
The interventions under investigation include: transcatheter aortic valve replacement (TAVR) (PROCEDURE), surgical aortic valve replacement (SAVR) (PROCEDURE).
Who is sponsoring clinical trial NCT06817148?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06817148 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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