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Clinical Trials/NCT03453567
NCT03453567
Active, Not Recruiting
N/A

Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Seung-Jung Park3 sites in 1 country900 target enrollmentMay 10, 2018
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ConditionsAortic Valve DiseaseAortic Valve Stenosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aortic Valve Disease
Sponsor
Seung-Jung Park
Enrollment
900
Locations
3
Primary Endpoint
All-cause death
Status
Active, Not Recruiting
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.

Registry
clinicaltrials.gov
Start Date
May 10, 2018
End Date
December 15, 2030
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Seung-Jung Park
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

Professor, Division of Cardiology

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Age 19 and more
  • •Patient with aortic valve replacement

Exclusion Criteria

  • •Combined with mitral stenosis requiring surgery or aorta stenosis
  • •Acute bacterial endocarditis within 1 month of valve replacement

Outcomes

Primary Outcomes

All-cause death

Time Frame: 1 year

Secondary Outcomes

  • New onset atrial fibrillation(30 days and 1 year)
  • Cardiovascular mortality(5 years)
  • NYHA class(30 days and 1 year)
  • Acute kidney injury(5 years)
  • TAVR-related complication(5 years)
  • Composite event(5 years)
  • Structural valve deterioration(5 years)
  • The change of valve area(30 days and 1 year)
  • Myocardial infarction(5 years)
  • All stroke and transient ischemic attack(5 years)
  • Permanent pacemaker insertion(5 years)
  • Prosthetic valve dysfunction(5 years)
  • Bleeding(5 years)
  • Access site complication(5 years)

Study Sites (3)

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