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Compares treatment options for Aortic Valve Stenosis
Official title Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
ClinicalTrials.gov ID: NCT06817148
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged \> 50 years of age
- Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
- Gated contrast CT available and suitable for core laboratory analysis
You likely can't join if
- Recent cardiovascular intervention within the prior 30 days.
- Presence of an existing TAVR or SAVR device
- Pregnancy or lactation
- Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
- Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
- Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\<45 mm but site plan for...
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged \> 50 years of age
- Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
- Gated contrast CT available and suitable for core laboratory analysis
- BAV anatomy confirmed by CT core laboratory analysis
- Recent cardiovascular intervention within the prior 30 days.
- Presence of an existing TAVR or SAVR device
- Pregnancy or lactation
- Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
- Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
- Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\<45 mm but site plan for surgery of the aorta in the event of randomization to surgery
- Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root...
- In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.