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NCT Number: NCT05439863

TAVR for Aortic Valve Disease

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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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

patients refuse the clinical follow-up

Treatment and study plan

transcatheter heart valve

Device

patients with severe aortic valve disease underwent transcatheter heart valve

Primary outcomes

  1. all-cause death during follow-up

    Time frame: 5 years

    all-cause death during 5-year follow-up

Secondary outcomes

  1. cardiac death during follow-up

    Time frame: 5 years

    Cardiac death during 5-year follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Kan, MPH

CONTACT

[email protected]

+86-25-52271398

Jun-Jie Zhang, MD

CONTACT

[email protected]

+86-25-52271350

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2032
Study completion
2037
First posted
Jun 30, 2022
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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