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The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02394184
Acronym
Bicuspid TAVR
Enrollment
102
Registered
2015-03-20
Start date
2015-05-31
Completion date
2019-09-24
Last updated
2019-12-26

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

Conditions

Aortic Valve Stenosis, Bicuspid, Cardiovascular Diseases, Heart Valve Diseases

Keywords

transcatheter aortic valve replacement

Brief summary

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

Detailed description

This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Interventions

PROCEDUREtranscatheter aortic valve replacement

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Seung-Jung Park
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with bicuspid aortic valve stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses. * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Design outcomes

Primary

MeasureTime frame
Death1 month

Secondary

MeasureTime frame
Death from cardiac cause1 month
Stroke1 month
Myocardial infarction1 month
Repeat hospitalization1 month
Acute kidney injury1 month
Vascular complication1 month
Bleeding events1 month
Device success1 month
Early safety as a composite of all cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure1 month
Clinical Efficacy as a composite of all cause mortality, all stroke, hospitalization for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic heart valve dysfunction1 month, 6 months, and annually at 1 to 5 years
Time related valve safety as a composite of structural valve deterioration, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, VARC bleeding(unless clearly unrelated to valve therapy)from index procedure to 5 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026