TAVR for Aortic Valve Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: transcatheter heart valve

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Jun-Jie Zhang, MD; Phone Number: +86-25-52271350; Email: jameszll@163.com
• Study Contact Backup: Name: Jing Kan, MPH; Phone Number: +86-25-52271398; Email: kanjingok@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Shao-Liang Chen; Phone Number: +86 13605157029; Email: chmengx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing transcatheter aortic valve replacement due to severe aortic valve stenosis or regurgitation were eligible into this registry.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause death during follow-up	all-cause death during 5-year follow-up	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac death during follow-up	Cardiac death during 5-year follow-up	5 years

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 30, 2032
• Study Completion (Estimated): December 30, 2037

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Aortic Valve Disease; Heart Defects, Congenital; Heart Valve Diseases
• Other Study ID Numbers: NanjingValve Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No