Clinical Trials/NCT05439863

NCT05439863

Recruiting

N/A

Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry

Nanjing First Hospital, Nanjing Medical University1 site in 1 country5,000 target enrollmentJuly 1, 2022

ConditionsAortic Valve Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Aortic Valve Disease
Sponsor: Nanjing First Hospital, Nanjing Medical University
Enrollment: 5000
Locations: 1
Primary Endpoint: all-cause death during follow-up
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 30, 2037

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Nanjing First Hospital, Nanjing Medical University

Responsible Party

Principal Investigator

Principal Investigator

Junjie Zhang

Vice chief

Nanjing First Hospital, Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of severe aortic stenosis or aortic regurgitation
•Patients undergo transcatheter aortic valve replacement

Exclusion Criteria

•patients refuse the clinical follow-up

Outcomes

Primary Outcomes

all-cause death during follow-up

Time Frame: 5 years

all-cause death during 5-year follow-up

Secondary Outcomes

cardiac death during follow-up(5 years)

Study Sites (1)

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