The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

Cardiovascular Diseases Clinical Trial

— Bicuspid TAVR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394184
• Other study ID #: AMCCV2014-14_sub
• Status: Completed
• Start date: May 2015
• Est. completion date: September 24, 2019

Study information

• Verified date: December 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bicuspid
• Cardiovascular Diseases
• Constriction, Pathologic
• Heart Valve Diseases

Intervention

Procedure:
• transcatheter aortic valve replacement

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		1 month
Primary	Death		6 months
Primary	Death		1 year
Primary	Death		2 years
Primary	Death		3 years
Primary	Death		4 years
Primary	Death		5 years
Secondary	Death from cardiac cause		1 month
Secondary	Death from cardiac cause		6 months
Secondary	Death from cardiac cause		1 year
Secondary	Death from cardiac cause		2 years
Secondary	Death from cardiac cause		3 years
Secondary	Death from cardiac cause		4 years
Secondary	Death from cardiac cause		5 years
Secondary	Stroke		1 month
Secondary	Stroke		6 months
Secondary	Stroke		1 year
Secondary	Stroke		2 years
Secondary	Stroke		3 years
Secondary	Stroke		4 years
Secondary	Stroke		5 years
Secondary	Myocardial infarction		1 month
Secondary	Myocardial infarction		6 months
Secondary	Myocardial infarction		1 year
Secondary	Myocardial infarction		2 years
Secondary	Myocardial infarction		3 years
Secondary	Myocardial infarction		4 years
Secondary	Myocardial infarction		5 years
Secondary	Repeat hospitalization		1 month
Secondary	Repeat hospitalization		6 months
Secondary	Repeat hospitalization		1 year
Secondary	Repeat hospitalization		2 years
Secondary	Repeat hospitalization		3 years
Secondary	Repeat hospitalization		4 years
Secondary	Repeat hospitalization		5 years
Secondary	Acute kidney injury		1 month
Secondary	Acute kidney injury		6 months
Secondary	Acute kidney injury		1 year
Secondary	Acute kidney injury		2 years
Secondary	Acute kidney injury		3 years
Secondary	Acute kidney injury		4 years
Secondary	Acute kidney injury		5 years
Secondary	Vascular complication		1 month
Secondary	Vascular complication		6 months
Secondary	Vascular complication		1 year
Secondary	Vascular complication		2 years
Secondary	Vascular complication		3 years
Secondary	Vascular complication		4 years
Secondary	Vascular complication		5 years
Secondary	Bleeding events		1 month
Secondary	Bleeding events		6 months
Secondary	Bleeding events		1 year
Secondary	Bleeding events		2 years
Secondary	Bleeding events		3 years
Secondary	Bleeding events		4 years
Secondary	Bleeding events		5 years
Secondary	Device success		1 month
Secondary	Device success		6 months
Secondary	Device success		1 year
Secondary	Device success		2 years
Secondary	Device success		3 years
Secondary	Device success		4 years
Secondary	Device success		5 years
Secondary	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
Secondary	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
Secondary	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