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Clinical Trials/NCT03793296
NCT03793296
Withdrawn
Not Applicable

Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study

Seung-Jung Park1 site in 1 countryJanuary 31, 2019
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ConditionsCardiac ValvesHeart Valve DiseasesValvular Insufficiency

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Valves
Sponsor
Seung-Jung Park
Locations
1
Primary Endpoint
Degree of para-valvular leakage
Status
Withdrawn
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.

Registry
clinicaltrials.gov
Start Date
January 31, 2019
End Date
December 31, 2026
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Seung-Jung Park
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

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

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
  • •Required treatment of paravalvular leakage due to heart failure or hemolysis
  • •There is a formal agreement of heart team as following
  • •predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)
  • •Inoperable status due to old age or frailty
  • •Written consent

Exclusion Criteria

  • •Risk of valve embolization because of valve dehiscence or instability
  • •Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
  • •Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
  • •Life expectancy less than 6 months due to non-cardiac disease
  • •Pregnant or breastfeeding

Outcomes

Primary Outcomes

Degree of para-valvular leakage

Time Frame: 1 month

classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)

Secondary Outcomes

  • Event rate of bleeding(1 month)
  • Event rate of device success(1 month)
  • Event rate of all cause death(up to 5 years)
  • Event rate of stroke(up to 5 years)
  • Event rate of myocardial infarction(up to 5 years)
  • Event rate of acute kidney injury(1 month)
  • Event rate of cardiac death(up to 5 years)
  • Event rate of rehospitalization(up to 5 years)
  • Event rate of infection(up to 5 years)
  • Event rate of vascular complication(1 month)

Study Sites (1)

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