The Asian Pacific TAVR Multicenter Registry

NCT ID: NCT02195102

Last Updated: 2014-11-18

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

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2021-12-31

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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Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Groups

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transcatheter aortic valve Replacement

Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.

Transcatheter aortic valve Replacement

Intervention Type DEVICE

Interventions

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Transcatheter aortic valve Replacement

Intervention Type DEVICE

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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Asan Medical Center

OTHER

Sponsor Role collaborator

Cardiovascular Clinical Research

INDUSTRY

Sponsor Role collaborator

Michael Kang-Yin Lee, MD

OTHER

Sponsor Role lead

Responsible Party

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Michael Kang-Yin Lee, MD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center, Republic of Korea

Edgar L.W. Tay, MD

Role: PRINCIPAL_INVESTIGATOR

National University Heart Center (National University Health System), Singapore

Machael Kang-Yin Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, HongKong

Locations

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Queen Elizabeth Hospital

Hong Kong, , China

Site Status

Nanjing 1st Hospital

Nanjing, , China

Site Status

Shonan Kamakura General Hospital

Kamakura, , Japan

Site Status

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Site Status

St. Luke's Medical Center

Bonifacio, , Philippines

Site Status

National Heart Centre of Singapore

Singapore, , Singapore

Site Status

National University Heart Centre

Singapore, , Singapore

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

National Taiwan University

Taipei, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Countries

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China Japan Malaysia Philippines Singapore South Korea Taiwan Thailand

Central Contacts

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Elly Jeong-youn Bae, Research Nurse

Role: CONTACT

Facility Contacts

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Michael Kang-Yin Lee, MD

Role: primary

Jun-Jie Zhang, MD

Role: primary

Shigeru Saito, MD

Role: primary

Rosli Mohd Ali, MD

Role: primary

Enrique Fabio Posas, MD

Role: primary

Paul Chiam, MD

Role: primary

Edgar L.W. Tay, MD

Role: primary

Jeong-youn Bae, Research nurse

Role: primary

Paul Kao, MD

Role: primary

Wacin Buddhari, MD

Role: primary

Other Identifiers

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AMCCV 2013-12

Identifier Type: -

Identifier Source: org_study_id