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Clinical Trials/NCT03826264
NCT03826264
Recruiting
Not Applicable

a Multinational Multicenter Prospective Transpacific TAVR Registry

Duk-Woo Park, MD7 sites in 3 countries10,000 target enrollmentJune 15, 2019
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ConditionsHeart Valve DiseasesAortic Valve Insufficiency

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Valve Diseases
Sponsor
Duk-Woo Park, MD
Enrollment
10000
Locations
7
Primary Endpoint
Event rate of all cause death
Status
Recruiting
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2019
End Date
December 31, 2036
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Duk-Woo Park, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Duk-Woo Park, MD

Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • •All patients undergoing TAVR
  • •Informed consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Event rate of all cause death

Time Frame: 1 year

Secondary Outcomes

  • Event rate of Permanent pacemaker insertion(10 years)
  • NYHA class(1 year)
  • Event rate of free from atrial fibrillation(10 years)
  • Event rate of bleeding(10 years)
  • Event rate of cerebrovascular accident(10 years)
  • Event rate of Vascular access site and access-related complication(30 days)
  • Event rate of Prosthetic valve dysfunction(10 years)
  • Event rate of Composite endpoint(10 years)
  • Event rate of Structural valve deterioration(10 years)
  • Event rate of cardiovascular death(10 years)
  • Event rate of myocardial infarction(10 years)
  • Event rate of Acute kidney injury(30 days)
  • Event rate of Other TAVR-related complication(10 years)
  • Valve area(1 year)

Study Sites (7)

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