Recruiting

Transcatheter Aortic Valve Replacement

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03836521

Conditions

Bicuspid Aortic Valve

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcatheter aortic valve replacement

Study Details

Brief summary:

The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.

Conditions

Bicuspid Aortic Valve

Study ID

NCT03836521

Start date

Aug 15, 2016

Status verified date

Feb, 2019

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Aug 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Transcatheter aortic valve replacement

Primary outcome measure

  • Death [ Time Frame: 1 month ]
  • Death [ Time Frame: 1 year ]
  • Death [ Time Frame: 2 years ]
  • Death [ Time Frame: 3 years ]
  • Death [ Time Frame: 4 years ]
  • Death [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Sung-Han Yoon, M.D.

3104237426Sunghan.Yoon@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Sung-Han Yoon, M.D.

310-423-7426Sunghan.Yoon@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Feb 11, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2019-02-11.