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

Heart Valve Diseases Clinical Trial

— PVL closure  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03793296
• Other study ID #: AMCCV2018-11
• Status: Withdrawn
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Valves
• Heart Valve Diseases
• Valvular Insufficiency

Intervention

Device:
• Percutaneous Device Closure: Vascular plug
percutaneous transcatheter approach into cardiac valve

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Event rate of all cause death		up to 5 years
Secondary	Event rate of cardiac death		up to 5 years
Secondary	Event rate of stroke		up to 5 years
Secondary	Event rate of myocardial infarction		up to 5 years
Secondary	Event rate of rehospitalization		up to 5 years
Secondary	Event rate of infection	Valve related infection or infective endocarditis	up to 5 years
Secondary	Event rate of acute kidney injury		1 month
Secondary	Event rate of vascular complication		1 month
Secondary	Event rate of bleeding		1 month
Secondary	Event rate of device success		1 month