Transpacific TAVR Registry

Recruiting

• Conditions: Heart Valve Diseases; Aortic Valve Insufficiency
• Interventions: Procedure: TAVR

• Registration Number: NCT03826264
• Lead Sponsor: Duk-Woo Park, MD

Brief Summary

This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.

Detailed Description

This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-06
• Primary Completion: 2035-12-31
• Study Completion: 2036-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• All patients undergoing TAVR
• Informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Northwestern University	TAVR	Evanston, Illinois, USA All Patients undergoing TAVR
Korea Centers	TAVR	Seoul, Korea All Patients undergoing TAVR
Stanford University	TAVR	California, USA All Patients undergoing TAVR
Cheng-Hsin Hospital	TAVR	Taipei, Taiwan All Patients undergoing TAVR

Primary Outcome Measures

Name	Time	Method
Event rate of all cause death	1 year

Secondary Outcome Measures

Name	Time	Method
Valve area	1 year
Event rate of Permanent pacemaker insertion	10 years
NYHA class	1 year
Event rate of free from atrial fibrillation	10 years
Event rate of bleeding	10 years	according to Valve Academic Research Consortium (VARC) criteria
Event rate of cerebrovascular accident	10 years	stroke and TIA (Transient Ischemic Attack)
Event rate of Vascular access site and access-related complication	30 days	according to Valve Academic Research Consortium (VARC) criteria
Event rate of Prosthetic valve dysfunction	10 years	according to Valve Academic Research Consortium (VARC) criteria; A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation
Event rate of Composite endpoint	10 years	A. Device success; B. Early safety; : death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention; C. Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class\* III, IV dyspnea, valve dysfunction; \*the New York Heart Association (NYHA) Functional Classification
Event rate of Structural valve deterioration	10 years
Event rate of cardiovascular death	10 years	A. Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause
Event rate of myocardial infarction	10 years	according to Valve Academic Research Consortium (VARC) criteria
Event rate of Acute kidney injury	30 days
Event rate of Other TAVR-related complication	10 years	A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment

Trial Locations

Locations (7)

Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China

Bucheon Sejong Hospital; 🇰🇷 Bucheon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

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

Stanford University; 🇺🇸 Stanford, California, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States