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NCT Number: NCT03826264

Transpacific TAVR Registry

This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.

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Key information

Conditions

Heart Valve Diseases Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital of Zhejiang University, Hangzhou, China

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About this study

This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.

Who can participate

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

Inclusion criteria

  • All patients undergoing TAVR
  • Informed consent

Treatment and study plan

TAVR

Procedure

transcatheter aortic valve replacement (TAVR)

Primary outcomes

  1. Event rate of all cause death

    Time frame: 1 year

Secondary outcomes

  1. Event rate of cardiovascular death

    Time frame: 10 years

    A. Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause

  2. Event rate of myocardial infarction

    Time frame: 10 years

    according to Valve Academic Research Consortium (VARC) criteria

  3. Event rate of cerebrovascular accident

    Time frame: 10 years

    stroke and TIA (Transient Ischemic Attack)

  4. Event rate of bleeding

    Time frame: 10 years

    according to Valve Academic Research Consortium (VARC) criteria

  5. Event rate of Vascular access site and access-related complication

    Time frame: 30 days

    according to Valve Academic Research Consortium (VARC) criteria

  6. Event rate of Acute kidney injury

    Time frame: 30 days

  7. Event rate of Permanent pacemaker insertion

    Time frame: 10 years

  8. Event rate of Other TAVR-related complication

    Time frame: 10 years

    A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment

  9. Event rate of Prosthetic valve dysfunction

    Time frame: 10 years

    according to Valve Academic Research Consortium (VARC) criteria

    A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation

  10. Event rate of Composite endpoint

    Time frame: 10 years

    A. Device success

    B. Early safety

    : death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention

    C. Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class* III, IV dyspnea, valve dysfunction

    *the New York Heart Association (NYHA) Functional Classification

  11. Event rate of Structural valve deterioration

    Time frame: 10 years

  12. NYHA class

    Time frame: 30 days

  13. NYHA class

    Time frame: 1 year

  14. Valve area

    Time frame: 1 year

  15. Event rate of free from atrial fibrillation

    Time frame: 10 years

Study contacts

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

Do-yoon Kang, MD

CONTACT

[email protected]

Duk-woo Park, MD

CONTACT

[email protected]

82230103995

Sponsors and collaborators

Lead sponsor

Duk-Woo Park, MD

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

a Multinational Multicenter Prospective Transpacific TAVR Registry

Acronym: TP-TAVR

Important dates

Study start
2019
Primary completion
2035
Study completion
2036
First posted
Feb 1, 2019
Registry last updated
Jan 2, 2026

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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