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

Seung-Jung Park1 site in 1 country102 target enrollmentMay 2015

ConditionsAortic Valve Stenosis Cardiovascular Diseases Heart Valve Diseases Bicuspid

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Seung-Jung Park
Enrollment: 102
Locations: 1
Primary Endpoint: Death
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

September 24, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

MD, PhD

Asan Medical Center

Eligibility Criteria

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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Death

Time Frame: 5 years

Secondary Outcomes

Vascular complication(5 years)
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 procedure(1 month)
Bleeding events(5 years)
Death from cardiac cause(5 years)
Acute kidney injury(5 years)
Stroke(5 years)
Myocardial infarction(5 years)
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 dysfunction(1 month, 6 months, and annually at 1 to 5 years)
Repeat hospitalization(5 years)
Device success(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)