TAVR for Aortic Valve Disease

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439863
• Other study ID #: NanjingValve Registry
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 30, 2037

Study information

• Verified date: August 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jun-Jie Zhang, MD
• Phone: +86-25-52271350
• Email: jameszll[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2037
• Est. primary completion date: December 30, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Device:
• transcatheter heart valve
patients with severe aortic valve disease underwent transcatheter heart valve

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause death during follow-up	all-cause death during 5-year follow-up	5 years
Secondary	cardiac death during follow-up	Cardiac death during 5-year follow-up	5 years