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Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03836521
Enrollment
2000
Registered
2019-02-11
Start date
2016-08-15
Completion date
2028-08-15
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bicuspid Aortic Valve

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.

Interventions

DEVICETranscatheter aortic valve replacement

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 129 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Death1 monthDeath from any cause

Secondary

MeasureTime frameDescription
Death from cardiac cause1 monthDeath from cardiac cause
Stroke1 monthdisabling and non-disabling stroke
Repeat hospitalization1 monthNumber of hospitalizations
Bleeding1 monthLife-threatening or major bleeding rate
Vascular complication1 monthMajor vascular complication
Acute kidney injury (stage 2 or 3)1 month
Prosthetic regurgitation by Doppler echocardiographyat discharge
Mean aortic valve gradient by Doppler echocardiography1 month

Countries

United States

Contacts

Primary ContactSung-Han Yoon, M.D.
Sunghan.Yoon@cshs.org3104237426

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026