Evaluating outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valves
The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
This study is testing how well transcatheter aortic valve replacement works for people with severe aortic stenosis caused by a bicuspid aortic valve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 19 Years to 129 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03836521 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the procedural and clinical outcomes for patients suffering from severe aortic stenosis due to bicuspid aortic valve anatomy who are undergoing transcatheter aortic valve replacement (TAVR). The study will involve a comprehensive evaluation by a Heart Team to determine the appropriateness of TAVR for each patient. Data collected will help to understand the effectiveness and safety of this intervention in the specified patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with severe aortic stenosis and bicuspid valve anatomy who are symptomatic.
Not a fit: Patients who are asymptomatic or have pure aortic regurgitation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with bicuspid aortic valve stenosis.
How similar studies have performed: There have been previous studies on TAVR for aortic stenosis, but the specific focus on bicuspid aortic valves is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age≥18 years. 2. Severe aortic stenosis with bicuspid anatomy. 3. NYHA≥2 and/or syncope and/or angina. 4. Patient judged by the Heart Team as indicated for TAVR. Exclusion Criteria: 1. Age \<18 years 2. Asymptomatic patients 3. Pure aortic regurgitation.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Sung-Han Yoon, M.D.
- Email: Sunghan.Yoon@cshs.org
- Phone: 3104237426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.