Asian TAVR: The Asian Transcatheter Aortic Valve Replacement Registry

Sponsor

Seung-Jung Park (Other)

Overall Status

Completed

CT.gov ID

NCT02308150

Collaborator

CardioVascular Research Foundation, Korea (Other)

1,505

Enrollment

Locations

57.8

Duration (Months)

125.4

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Diseases	Device: transcatheter aortic valve replacement

Detailed Description

This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Study Design

Study Type:

Observational

Actual Enrollment :

1505 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Sep 24, 2019

Actual Study Completion Date :

Sep 24, 2019

Outcome Measures

Primary Outcome Measures

Death [1 month]
Death [6 months]
Death [1 year]
Death [2 years]
Death [3 years]
Death [4 years]
Death [5 years]

Secondary Outcome Measures

Death from cardiac cause [1 month]
Death from cardiac cause [6 months]
Death from cardiac cause [1 year]
Death from cardiac cause [2 years]
Death from cardiac cause [3 years]
Death from cardiac cause [4 years]
Death from cardiac cause [5 years]
Stroke [1 month]
Stroke [6 months]
Stroke [1 year]
Stroke [2 years]
Stroke [3 years]
Stroke [4 years]
Stroke [5 years]
Myocardial infarction [1 month]
Myocardial infarction [6 months]
Myocardial infarction [1 year]
Myocardial infarction [2 years]
Myocardial infarction [3 years]
Myocardial infarction [4 years]
Myocardial infarction [5 years]
Repeat hospitalization [1 month]
Repeat hospitalization [6 months]
Repeat hospitalization [1 year]
Repeat hospitalization [2 years]
Repeat hospitalization [3 years]
Repeat hospitalization [4 years]
Repeat hospitalization [5 years]
Acute kidney injury [1 month]
Acute kidney injury [6 months]
Acute kidney injury [1 year]
Acute kidney injury [2 years]
Acute kidney injury [3 years]
Acute kidney injury [4 years]
Acute kidney injury [5 years]
Vascular complication [1 month]
Vascular complication [6 months]
Vascular complication [1 year]
Vascular complication [2 years]
Vascular complication [3 years]
Vascular complication [4 years]
Vascular complication [5 years]
Bleeding events [1 month]
Bleeding events [6 months]
Bleeding events [1 year]
Bleeding events [2 years]
Bleeding events [3 years]
Bleeding events [4 years]
Bleeding events [5 years]
Device success [1 month]
Device success [6 months]
Device success [1 year]
Device success [2 years]
Device success [3 years]
Device success [4 years]
Device success [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth Hospital	Hong Kong		China
2	Shonan Kamakura General Hospital	Kamakura		Japan
3	Kokura Memorial Hospital	Kitakyushu		Japan
4	Keio University	Minato		Japan
5	Teikyo University School of medicine	Tokyo		Japan
6	Saiseikai Yokohama-city Eastern Hospital	Yokohama		Japan
7	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736
8	Sejong Hospital	Bucheon		Korea, Republic of
9	Chungnam National University Hospital	Daejeon		Korea, Republic of
10	Seoul National University Hospital	Seoul		Korea, Republic of
11	National University Heart Centre	Singapore		Singapore
12	National Taiwan University	Taipei		Taiwan

Sponsors and Collaborators

Seung-Jung Park
CardioVascular Research Foundation, Korea

Investigators

Principal Investigator: Seung-jung Park, MD, Asan Medical Center
Principal Investigator: Paul Hsien Li Kao, MD, National Taiwan University, Taiwan
Principal Investigator: Shigeru Saito, MD, Shonan Kamakura General Hospital, Japan
Principal Investigator: Gerald Yong, MD, Royal Perth Hospital, Australia
Principal Investigator: Kentaro Hayashida, MD, Keio University, JAPAN