The Asian Transcatheter Aortic Valve Replacement Registry

Aortic Valve Stenosis Clinical Trial

— Asian TAVR  

Official title:

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308150
• Other study ID #: AMCCV2014-14
• Status: Completed
• Start date: December 2014
• Est. completion date: September 24, 2019

Study information

• Verified date: September 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 the Asian Pacific population

Description:

This 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: 1505
• 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 symptomatic severe aortic 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 Diseases
• Aortic Valve Stenosis

Intervention

Device:
• transcatheter aortic valve replacement

Locations

Country	Name	City	State
China	Queen Elizabeth Hospital	Hong Kong
Japan	Shonan Kamakura General Hospital	Kamakura
Japan	Kokura Memorial Hospital	Kitakyushu
Japan	Keio University	Minato
Japan	Teikyo University School of medicine	Tokyo
Japan	Saiseikai Yokohama-city Eastern Hospital	Yokohama
Korea, Republic of	Sejong Hospital	Bucheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Seoul National University Hospital	Seoul
Singapore	National University Heart Centre	Singapore
Taiwan	National Taiwan University	Taipei

Sponsors (2)

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

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

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