TAVR for Aortic Valve Disease

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05439863
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1
• Anticipated Duration (Months): 186
• Patients Per Site Per Month: 26.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Device: transcatheter heart valve

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2032
• Anticipated Study Completion Date: Dec 30, 2037

Arms and Interventions

Arm	Intervention/Treatment
TAVR in aortic valve disease	Device: transcatheter heart valve; patients with severe aortic valve disease underwent transcatheter heart valve

Outcome Measures

Primary Outcome Measures

1. all-cause death during follow-up [5 years]

   all-cause death during 5-year follow-up

Secondary Outcome Measures

1. cardiac death during follow-up [5 years]

   Cardiac death during 5-year follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China	210006

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junjie Zhang, Vice chief, Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05439863
• Other Study ID Numbers: NanjingValve Registry
• First Posted: Jun 30, 2022
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Disease; Heart Defects, Congenital; Heart Valve Diseases

Study Results

No Results Posted as of Aug 11, 2022