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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: Recruiting NA study of Aortic Valve Stenosis and Bicuspid Aortic Valve, sponsored by Cedars-Sinai Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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%
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 |
What NCT06817148 shows while recruiting
NCT06817148 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,035-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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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Where NCT06817148's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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