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Recruiting NCT03826264

Transpacific TAVR Registry

— Observational Heart Valve Diseases Aortic Valve Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAVR.
Who it may be relevant to
Registry conditions: Heart Valve Diseases, Aortic Valve Insufficiency. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

a Multinational Multicenter Prospective Transpacific TAVR Registry

Overview

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

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.

Interventions

  • Procedure TAVR
    transcatheter aortic valve replacement (TAVR)

Primary outcome measures

  • Event rate of all cause death [Time frame: 1 year]
Secondary outcome measures (12)
  • Event rate of cardiovascular death [Time frame: 10 years]
  • Event rate of myocardial infarction [Time frame: 10 years]
  • Event rate of cerebrovascular accident [Time frame: 10 years]
  • Event rate of bleeding [Time frame: 10 years]
  • Event rate of Vascular access site and access-related complication [Time frame: 30 days]
  • Event rate of Acute kidney injury [Time frame: 30 days]
  • Event rate of Permanent pacemaker insertion [Time frame: 10 years]
  • Event rate of Other TAVR-related complication [Time frame: 10 years]
  • Event rate of Prosthetic valve dysfunction [Time frame: 10 years]
  • Event rate of Composite endpoint [Time frame: 10 years]
  • Event rate of Structural valve deterioration [Time frame: 10 years]
  • NYHA class [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • All patients undergoing TAVR
  • Informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

South Korea · 4 centers
  • Bucheon Sejong Hospital — Bucheon-si
  • Chungnam National University Hospital — Daejeon
  • Asan Medical Center — Seoul
  • Seoul National University Hospital — Seoul
United States · 2 centers
  • Stanford University — Stanford
  • Northwestern Memorial Hospital — Chicago
China · 1 center
  • Second Affiliated Hospital of Zhejiang University — Hangzhou

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. PMID 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. PMID 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. PMID 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. PMID 34838464

Identifiers

NCT: NCT03826264 · AMCCV2019-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗