Evaluating outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valves

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Transcatheter and Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Patients

  This study is testing whether a new heart valve replacement method works better than the traditional surgery for people with severe aortic stenosis and a bicuspid aortic valve.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT06817148

• Genetic testing for predicting early aortic valve disease in patients with bicuspid aortic valves

  This study is testing how genetic factors might affect the early development of aortic valve disease in people with bicuspid aortic valves.

  Recruiting Yonsei University · Seoul · NCT06153407

• Assessing changes in aortic diameter after valve replacement

  This study looks at how the size of the aorta changes after patients have a heart valve replacement to see if it gets bigger or stays the same, especially for those who already had a larger aorta.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT05739253

• Comparing two ways to stabilize the bicuspid aortic valve during repair

  This trial will test whether an internal HAART 200 annuloplasty device or a double external ring annuloplasty gives better repair results for adults with asymmetric bicuspid aortic valves and severe aortic regurgitation who need valve surgery.

  Recruiting at 2 sites University Hospital Augsburg · Augsburg, Bavaria and 3 other locations · NCT06869954

• Sapien 3 TAVR for younger adults with aortic stenosis in China

  This project tries the Sapien 3 transcatheter aortic valve replacement (TAVR) in people aged 50–70 with severe aortic stenosis, including bicuspid valves, to see if it is safe, effective, and durable.

  Recruiting at 2 sites Xijing Hospital · Xi'an, Shaanxi and 3 other locations · NCT06830499

• Observing the progression of bicuspid aortic valve in Chinese patients

  This study looks at how bicuspid aortic valve affects young Chinese patients over time to better understand the condition and improve treatment options.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT06802016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.