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Transpacific TAVR Registry (TP-TAVR)

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ClinicalTrials.gov Identifier: NCT03826264
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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

Condition or disease Intervention/treatment
Heart Valve Diseases Aortic Valve Insufficiency Procedure: TAVR

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: a Multinational Multicenter Prospective Transpacific TAVR Registry
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2031

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)




Primary Outcome Measures :
  1. Event rate of all cause death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients undergoing TAVR
Criteria

Inclusion Criteria:

  • All patients undergoing TAVR
  • Informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826264


Contacts
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Contact: Duk-woo Park, MD 82230103995 dwpark@amc.seoul.kr
Contact: Do-yoon Kang, MD kdy1218@gmail.com

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Alan Ching Yuen Yeung, MD       ayeung@stanford.edu   
Principal Investigator: Alan Ching Yuenn Yeung, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: James D. Flaherty, MD       jflahert@nm.org   
Principal Investigator: James D. Flaherty, MD         
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Taiwan
Cheng Hsin General Hospital Recruiting
Taipei, Taiwan
Contact: Wei Hsian Yin, MD       yinwh88@gmail.com   
Principal Investigator: Wei Hsian Yin, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Alan Ching Yuen Yeung, MD Stanford University
Principal Investigator: James D. Flaherty, MD Northwestern University

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Responsible Party: Seung-Jung Park, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03826264     History of Changes
Other Study ID Numbers: AMCCV2019-01
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung-Jung Park, Asan Medical Center:
TAVR
TAVI
real-world
Additional relevant MeSH terms:
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Heart Valve Diseases
Aortic Valve Insufficiency
Heart Diseases
Cardiovascular Diseases