Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement (PVL closure)

Seung-Jung Park

Status: Withdrawn

Conditions: Heart Valve Diseases; Valvular Insufficiency; Cardiac Valves

Treatments: Device: Percutaneous Device Closure: Vascular plug

Study type: Interventional

Funder types: Other

Identifiers

NCT03793296

AMCCV2018-11

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Paravalvular leak

Experimental group

Description:

After transcatheter- or surgical valve replacement

Treatment:

Device: Percutaneous Device Closure: Vascular plug