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

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

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

Conditions
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Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency

Intervention / Treatment
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* Device: Percutaneous Device Closure: Vascular plug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paravalvular leak<br>After transcatheter- or surgical valve replacement | Device: Percutaneous Device Closure: Vascular plug<br>* percutaneous transcatheter approach into cardiac valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of para-valvular leakage | classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of all cause death |  | up to 5 years | 
| Event rate of cardiac 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 rehospitalization |  | up to 5 years | 
| Event rate of infection | Valve related infection or infective endocarditis | up to 5 years | 
| Event rate of acute kidney injury |  | 1 month | 
| Event rate of vascular complication |  | 1 month | 
| Event rate of bleeding |  | 1 month | 
| Event rate of device success |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paravalvular leak