The Asian Transcatheter Aortic Valve Replacement Registry

NCT ID: NCT02308150

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-09-24

Brief Summary

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

Detailed Description

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

Conditions

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Aortic Valve Stenosis Aortic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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transcatheter aortic valve replacement

Intervention Type DEVICE

Other Intervention Names

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TAVR

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-jung Park, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Paul Hsien Li Kao, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Shonan Kamakura General Hospital, Japan

Gerald Yong, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital, Australia

Kentaro Hayashida, MD

Role: PRINCIPAL_INVESTIGATOR

Keio University, JAPAN

Locations

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Queen Elizabeth Hospital

Hong Kong, , China

Site Status

Shonan Kamakura General Hospital

Kamakura, , Japan

Site Status

Kokura Memorial Hospital

Kitakyushu, , Japan

Site Status

Keio University

Minato, , Japan

Site Status

Teikyo University School of medicine

Tokyo, , Japan

Site Status

Saiseikai Yokohama-city Eastern Hospital

Yokohama, , Japan

Site Status

National University Heart Centre

Singapore, , Singapore

Site Status

Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Sejong Hospital

Bucheon-si, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

National Taiwan University

Taipei, , Taiwan

Site Status

Countries

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China Japan Singapore South Korea Taiwan

References

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Yoon SH, Ahn JM, Hayashida K, Watanabe Y, Shirai S, Kao HL, Yin WH, Lee MK, Tay E, Araki M, Yamanaka F, Arai T, Lin MS, Park JB, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Muramatsu T, Hanyu M, Kozuma K, Kim HS, Saito S, Park SJ; Asian TAVR Investigators. Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. JACC Cardiovasc Interv. 2016 May 9;9(9):926-33. doi: 10.1016/j.jcin.2016.01.047.

Reference Type DERIVED
PMID: 27151607 (View on PubMed)

Other Identifiers

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AMCCV2014-14

Identifier Type: -

Identifier Source: org_study_id

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