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

Not Applicable

Withdrawn

• Conditions: Heart Valve Diseases; Cardiac Valves; Valvular Insufficiency

• Registration Number: NCT03793296
• Lead Sponsor: Seung-Jung Park

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-30
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Study Start: 2019-01-31
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01
• Primary Completion: 2021-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Valve related infection or infective endocarditis
Event rate of vascular complication	1 month

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of