NCT05439863

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
142mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jul 2022Dec 2037

First Submitted

Initial submission to the registry

May 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2032

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2037

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

10.5 years

First QC Date

May 27, 2022

Last Update Submit

November 13, 2024

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • all-cause death during follow-up

    all-cause death during 5-year follow-up

    5 years

Secondary Outcomes (1)

  • cardiac death during follow-up

    5 years

Study Arms (1)

TAVR in aortic valve disease

Device: transcatheter heart valve

Interventions

transcatheter heart valveDEVICE

patients with severe aortic valve disease underwent transcatheter heart valve

TAVR in aortic valve disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients refuse the clinical follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Jun-Jie Zhang, MD

CONTACT

+86-25-52271350jameszll@163.com

Jing Kan, MPH

CONTACT

+86-25-52271398kanjingok@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice chief

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 30, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

December 30, 2032

Study Completion (Estimated)

December 30, 2037

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)