Transpacific TAVR Registry

Heart Valve Diseases Clinical Trial

— TP-TAVR  

Official title:

a Multinational Multicenter Prospective Transpacific TAVR Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03826264
• Other study ID #: AMCCV2019-01
• Status: Recruiting
• Start date: June 15, 2019
• Est. completion date: December 31, 2031

Study information

• Verified date: June 2023
• Source: Asan Medical Center
• Contact: Duk-woo Park, MD
• Phone: 82230103995
• Email: dwpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing TAVR

• Informed consent

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Heart Valve Diseases

Intervention

Procedure:
• TAVR
transcatheter aortic valve replacement (TAVR)

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University	Hangzhou
Korea, Republic of	Bucheon Sejong Hospital	Bucheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

United States,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate of all cause death		1 year
Secondary	Event rate of cardiovascular death	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	10 years
Secondary	Event rate of myocardial infarction	according to Valve Academic Research Consortium (VARC) criteria	10 years
Secondary	Event rate of cerebrovascular accident	stroke and TIA (Transient Ischemic Attack)	10 years
Secondary	Event rate of bleeding	according to Valve Academic Research Consortium (VARC) criteria	10 years
Secondary	Event rate of Vascular access site and access-related complication	according to Valve Academic Research Consortium (VARC) criteria	30 days
Secondary	Event rate of Acute kidney injury		30 days
Secondary	Event rate of Permanent pacemaker insertion		10 years
Secondary	Event rate of Other TAVR-related complication	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	10 years
Secondary	Event rate of Prosthetic valve dysfunction	according to Valve Academic Research Consortium (VARC) criteria; A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation	10 years
Secondary	Event rate of Composite endpoint	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	10 years
Secondary	Event rate of Structural valve deterioration		10 years
Secondary	NYHA class		30 days
Secondary	NYHA class		1 year
Secondary	Valve area		1 year
Secondary	Event rate of free from atrial fibrillation		10 years