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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: Clinical Trial NA study, sponsored by Cedars-Sinai Medical Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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\*)
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 |
What is known before NCT07413965 opens enrollment
NCT07413965 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Transcatheter Aortic Valve Replacement is the first listed.
NCT07413965 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07413965's enrollment target sits among peer trials
1,200 83rd of 2000 higher than 1,912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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