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NCT07413965 · ClinicalTrials.gov registry record · NA
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
A NA study, sponsored by Cedars-Sinai Medical Center.
- Not yet
- Registry status
- NA
- Development phase
- 1,200
- Enrollment target
NCT07413965 is a NA study that has not yet begun recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 1,200 participants.
The verdict
NCT07413965, a NA study, has not yet begun recruiting, sponsored by Cedars-Sinai Medical Center.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 1,200 participants
- Enrollment target
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.
Interventions
- PROCEDURE Transcatheter Aortic Valve Replacement
- PROCEDURE the open chest surgery to replace the aortic valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2026-06-24 |
| Est. Completion | 2040-05-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07413965
The ClinicalTrials.gov registry entry for NCT07413965 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transcatheter Aortic Valve Replacement is the first listed.
NCT07413965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07413965 about?
NCT07413965 is a clinical study titled "TAVR vs SAVR in Severe Bicuspid Aortic Stenosis". 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 ...
What is the current status of trial NCT07413965?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 1,200 participants. The study started on 2026-06-24. Estimated completion is 2040-05-10.
What interventions are being tested in trial NCT07413965?
The interventions under investigation include: Transcatheter Aortic Valve Replacement (PROCEDURE), the open chest surgery to replace the aortic valve (PROCEDURE).
Who is sponsoring clinical trial NCT07413965?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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