Transpacific TAVR Registry (TP-TAVR)

a Multinational Multicenter Prospective Transpacific TAVR Registry

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

Study Overview

• Status: Recruiting
• Conditions: Heart Valve Diseases; Aortic Valve Insufficiency
• Intervention / Treatment: Procedure: TAVR

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Duk-woo Park, MD; Phone Number: 82230103995; Email: dwpark@amc.seoul.kr
• Study Contact Backup: Name: Do-yoon Kang, MD; Email: kdy1218@gmail.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital of Zhejiang University
    • Contact: Jian-an Wang, MD
    • Principal Investigator: Jian-an Wang, MD
• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Active, not recruiting
    • Bucheon Sejong Hospital
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam National University Hospital
    • Contact: Jae-hyung Park, MD
    • Principal Investigator: Jae-hyung Park, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Duk-woo Park, MD; Email: dwpark@amc.seoul.kr
    • Principal Investigator: Duk-woo Park, MD
  • Seoul, Korea, Republic of
    • Completed
    • Seoul National University Hospital
• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Alan Ching Yuen Yeung, MD
      • Principal Investigator: Alan Ching Yuenn Yeung, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Contact: James D. Flaherty, MD
      • Principal Investigator: James D. Flaherty, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All patients undergoing TAVR

Description

Inclusion Criteria:

• All patients undergoing TAVR
• Informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Korea Centers; Seoul, Korea All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)
Stanford University; California, USA All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)
Northwestern University; Evanston, Illinois, USA All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)
Cheng-Hsin Hospital; Taipei, Taiwan All Patients undergoing TAVR	Procedure: TAVR; transcatheter aortic valve replacement (TAVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event rate of all cause death	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA class		30 days
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	10 years
Event rate of myocardial infarction	according to Valve Academic Research Consortium (VARC) criteria	10 years
Event rate of cerebrovascular accident	stroke and TIA (Transient Ischemic Attack)	10 years
Event rate of bleeding	according to Valve Academic Research Consortium (VARC) criteria	10 years
Event rate of Vascular access site and access-related complication	according to Valve Academic Research Consortium (VARC) criteria	30 days
Event rate of Acute kidney injury		30 days
Event rate of Permanent pacemaker insertion		10 years
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	10 years
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	10 years
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	10 years
Event rate of Structural valve deterioration		10 years
NYHA class		1 year
Valve area		1 year
Event rate of free from atrial fibrillation		10 years

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Alan Ching Yuen Yeung, MD, Stanford University; Principal Investigator: James D. Flaherty, MD, Northwestern University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: TAVI; TAVR; real-world
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Aortic Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: AMCCV2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No