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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03793296

Acronym

PVL closure

Enrollment

Registered

2019-01-04

Start date

2019-01-31

Completion date

2026-12-31

Last updated

2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency

Keywords

Paravalvular leak

Brief summary

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

Interventions

DEVICEPercutaneous Device Closure: Vascular plug

percutaneous transcatheter approach into cardiac valve

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 all cause death	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	—
Event rate of infection	up to 5 years	Valve related infection or infective endocarditis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026