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Clinical Trials/NCT02308150
NCT02308150
Completed
Not Applicable

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population

Seung-Jung Park12 sites in 5 countries1,505 target enrollmentDecember 2014
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ConditionsAortic Valve StenosisAortic Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Stenosis
Sponsor
Seung-Jung Park
Enrollment
1505
Locations
12
Primary Endpoint
Death
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population

Detailed Description

This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
September 24, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Seung-Jung Park
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

MD, PhD

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses
  • •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Death

Time Frame: 5 years

Secondary Outcomes

  • Stroke(5 years)
  • Death from cardiac cause(5 years)
  • Vascular complication(5 years)
  • Device success(5 years)
  • Repeat hospitalization(5 years)
  • Bleeding events(5 years)
  • Acute kidney injury(5 years)
  • Myocardial infarction(5 years)

Study Sites (12)

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