NCT03826264

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
129mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
3 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jun 2019Dec 2036

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

16.6 years

First QC Date

January 30, 2019

Last Update Submit

December 28, 2025

Conditions

Heart Valve DiseasesAortic Valve Insufficiency

Keywords

TAVRTAVIreal-world

Outcome Measures

Primary Outcomes (1)

  • Event rate of all cause death

    1 year

Secondary Outcomes (15)

  • Event rate of cardiovascular death

    10 years

  • Event rate of myocardial infarction

    10 years

  • Event rate of cerebrovascular accident

    10 years

  • Event rate of bleeding

    10 years

  • Event rate of Vascular access site and access-related complication

    30 days

  • +10 more secondary outcomes

Study Arms (4)

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

TAVRPROCEDURE

transcatheter aortic valve replacement (TAVR)

Cheng-Hsin HospitalKorea CentersNorthwestern UniversityStanford University

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing TAVR

You may qualify if:

  • All patients undergoing TAVR
  • Informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Second Affiliated Hospital of Zhejiang University

Hangzhou, China

RECRUITING

Bucheon Sejong Hospital

Bucheon-si, South Korea

ACTIVE NOT RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

COMPLETED

Related Publications (4)

  • 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: 38660112DERIVED

  • 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: 37323869DERIVED

  • 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: 35110384DERIVED

  • 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.

    PMID: 34838464DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Valve Disease

Study Officials

  • Alan Ching Yuen Yeung, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • James D. Flaherty, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duk-woo Park, MD

CONTACT

82230103995dwpark@amc.seoul.kr

Do-yoon Kang, MD

CONTACT

kdy1218@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

June 15, 2019

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2036

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

KR(4)CN(1)US(2)