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RecruitingNCT03826264TP-TAVRUpdated Jan 2, 2026

Transpacific TAVR Registry

An observational study in Heart Valve Diseases and Aortic Valve Insufficiency, sponsored by Duk-Woo Park, MD. Recruiting at 7 sites in 3 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Duk-Woo Park, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Heart Valve Diseases
  • Aortic Valve Insufficiency

Keywords

  • TAVR
  • TAVI
  • real-world
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

All patients undergoing TAVR

Eligibility criteria

Inclusion Criteria:

  • All patients undergoing TAVR
  • Informed consent
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Korea Centers

    Seoul, Korea All Patients undergoing TAVR

    Procedure: TAVR

  • Stanford University

    California, USA All Patients undergoing TAVR

    Procedure: TAVR

  • Northwestern University

    Evanston, Illinois, USA All Patients undergoing TAVR

    Procedure: TAVR

  • Cheng-Hsin Hospital

    Taipei, Taiwan All Patients undergoing TAVR

    Procedure: TAVR

Interventions

  • ProcedureTAVR

    transcatheter aortic valve replacement (TAVR)

05

What researchers measure

Primary outcomes

  1. Event rate of all cause death

    Time frame: 1 year

Secondary outcomes

  1. Event rate of cardiovascular death

    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

    Time frame: 10 years

  2. Event rate of myocardial infarction

    according to Valve Academic Research Consortium (VARC) criteria

    Time frame: 10 years

  3. Event rate of cerebrovascular accident

    stroke and TIA (Transient Ischemic Attack)

    Time frame: 10 years

  4. Event rate of bleeding

    according to Valve Academic Research Consortium (VARC) criteria

    Time frame: 10 years

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

    according to Valve Academic Research Consortium (VARC) criteria

    Time frame: 30 days

  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

    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

    Time frame: 10 years

  9. Event rate of Prosthetic valve dysfunction

    according to Valve Academic Research Consortium (VARC) criteria A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation

    Time frame: 10 years

  10. Event rate of Composite endpoint

    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

    Time frame: 10 years

  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

06

Study locations

5 of 7 sites recruiting
  • Stanford University
    Stanford, California 94305, United States
    • Alan Ching Yuen Yeung, MD · Contact
    • Alan Ching Yuenn Yeung, MD · Principal investigator
    Recruiting
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
    • James D. Flaherty, MD · Contact
    • James D. Flaherty, MD · Principal investigator
    Recruiting
  • Second Affiliated Hospital of Zhejiang University
    Hangzhou, China
    • Jian-an Wang, MD · Contact
    • Jian-an Wang, MD · Principal investigator
    Recruiting
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    Active, not recruiting
  • Chungnam National University Hospital
    Daejeon, South Korea
    • Jae-hyung Park, MD · Contact
    • Jae-hyung Park, MD · Principal investigator
    Recruiting
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    Completed
07

References and documents

Publications

  • Kim M, Kang DY, Ahn JM, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim HJ, Lee J, Park J, Kim H, Cho S, Choi Y, Park SJ, Park DW. Sex-Specific Disparities in Clinical Outcomes After Transcatheter Aortic Valve Replacement Among Different Racial Populations. JACC Asia. 2024 Feb 13;4(4):292-302. doi: 10.1016/j.jacasi.2023.11.016. eCollection 2024 Apr. PubMed 38660112 ↗
  • Kim H, Kang DY, Ahn JM, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim N, Kim M, Lee J, Park J, Choi Y, Park SJ, Park DW. Race-Specific Impact of Conventional Surgical Risk Score on 1-Year Mortality After Transcatheter Aortic Valve Replacement. JACC Asia. 2023 Feb 28;3(3):376-387. doi: 10.1016/j.jacasi.2022.11.007. eCollection 2023 Jun. PubMed 37323869 ↗
  • Kang DY, Ahn JM, Kim JB, Yeung A, Nishi T, Fearon W, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Park SY, Yun SC, Ko E, Park H, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Inter-racial differences in patients undergoing transcatheter aortic valve implantation. Heart. 2022 Sep 12;108(19):1562-1570. doi: 10.1136/heartjnl-2021-320364. PubMed 35110384 ↗
  • Park H, Ahn JM, Kang DY, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim S, Yun SC, Ko E, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Racial Differences in the Incidence and Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2670-2681. doi: 10.1016/j.jcin.2021.08.038. Epub 2021 Nov 24. PubMed 34838464 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03826264
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Duk-Woo Park, MD (Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center) — Sponsor-investigator
First posted
Feb 1, 2019
Start date
Jun 15, 2019
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2036 (estimated)
Last update
Jan 2, 2026

Study contacts

Duk-woo Park, MD
Contact
dwpark@amc.seoul.kr
82230103995
Do-yoon Kang, MD
Contact
kdy1218@gmail.com
Alan Ching Yuen Yeung, MD
principal investigator · Stanford University
James D. Flaherty, MD
principal investigator · Northwestern University

Oversight

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

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