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RecruitingNCT05439863Updated Nov 15, 2024

TAVR for Aortic Valve Disease

An observational study in Aortic Valve Disease, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 112 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

patients refuse the clinical follow-up

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes

Groups and cohorts

  • TAVR in aortic valve disease

    Device: transcatheter heart valve

Interventions

  • Devicetranscatheter heart valve

    patients with severe aortic valve disease underwent transcatheter heart valve

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What researchers measure

Primary outcomes

  1. all-cause death during follow-up

    all-cause death during 5-year follow-up

    Time frame: 5 years

Secondary outcomes

  1. cardiac death during follow-up

    Cardiac death during 5-year follow-up

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • Nanjing First Hospital
    Nanjing, Jiangsu 210006, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05439863
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Junjie Zhang (Vice chief, Nanjing First Hospital, Nanjing Medical University) — Principal investigator
First posted
Jun 30, 2022
Start date
Jul 1, 2022
Primary completion
Dec 30, 2032 (estimated)
Completion
Dec 30, 2037 (estimated)
Last update
Nov 15, 2024

Study contacts

Jun-Jie Zhang, MD
Contact
jameszll@163.com
+86-25-52271350
Jing Kan, MPH
Contact
kanjingok@126.com
+86-25-52271398

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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