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Clinical Trials/NCT02195102
NCT02195102
Unknown
Not Applicable

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY

Michael Kang-Yin Lee, MD10 sites in 8 countries2,000 target enrollmentDecember 2014
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ConditionsAortic Valve Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Stenosis
Sponsor
Michael Kang-Yin Lee, MD
Enrollment
2000
Locations
10
Primary Endpoint
Death from any cause
Last Updated
11 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

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2021
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Michael Kang-Yin Lee, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Michael Kang-Yin Lee, MD

MD

Queen Elizabeth Hospital, Hong Kong

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 from any cause

Time Frame: 5 years

Secondary Outcomes

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

Study Sites (10)

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