The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

Completed

• Conditions: Aortic Valve Stenosis; Bicuspid; Cardiovascular Diseases; Heart Valve Diseases
• Interventions: Procedure: transcatheter aortic valve replacement

• Registration Number: NCT02394184
• Lead Sponsor: Seung-Jung Park

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.

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Study Start: 2015-05
• Primary Completion: 2019-09-24
• Study Completion: 2019-09-24
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-22
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with bicuspid aortic valve stenosis	transcatheter aortic valve replacement	-

Primary Outcome Measures

Name	Time	Method
Death	5 years

Secondary Outcome Measures

Name	Time	Method
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
Death from cardiac cause	5 years
Acute kidney injury	5 years
Stroke	5 years
Myocardial infarction	5 years
Bleeding events	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of