The Asian Pacific TAVR Multicenter Registry

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Transcatheter aortic valve Replacement

• Registration Number: NCT02195102
• Lead Sponsor: Michael Kang-Yin Lee, MD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18
• Study Start: 2014-12
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transcatheter aortic valve Replacement	Transcatheter aortic valve Replacement	Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.

Primary Outcome Measures

Name	Time	Method
Death from any cause	5 years

Secondary Outcome Measures

Name	Time	Method
Death from cardiac cause	5 years
Stroke	5 years
Myocardial infarction	5 years
Repeat hospitalization	5 years
Acute kidney injury	5 years
Vascular complication	5 years
Bleeding events	5 years
Device success	5 years	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \< 3 m/s, and no moderate or severe paravalvular regurgitation)

Trial Locations

Locations (10)

St. Luke's Medical Center; 🇵🇭 Bonifacio, Philippines

National Heart Centre of Singapore; 🇸🇬 Singapore, Singapore

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Institut Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia

Queen Elizabeth Hospital; 🇨🇳 HongKong, China

Shonan Kamakura General Hospital; 🇯🇵 Kamakura, Japan

National University Heart Centre; 🇸🇬 Singapore, Singapore

National Taiwan University; 🇨🇳 Taipei, Taiwan

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Nanjing 1st Hospital; 🇨🇳 Nanjing, China