TAVR for Aortic Valve Disease

Recruiting

• Conditions: Aortic Valve Disease
• Interventions: Device: transcatheter heart valve

• Registration Number: NCT05439863
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-26
• Study First Posted: 2022-06-30
• Study Start: 2022-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2032-12-30
• Study Completion: 2037-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Clinical diagnosis of severe aortic stenosis or aortic regurgitation
2. Patients undergo transcatheter aortic valve replacement

Exclusion Criteria

patients refuse the clinical follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVR in aortic valve disease	transcatheter heart valve	-

Primary Outcome Measures

Name	Time	Method
all-cause death during follow-up	5 years	all-cause death during 5-year follow-up

Secondary Outcome Measures

Name	Time	Method
cardiac death during follow-up	5 years	Cardiac death during 5-year follow-up

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China