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

Primary Purpose

Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous Device Closure: Vascular plug
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Valves focused on measuring Paravalvular leak

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paravalvular leak

Arm Description

After transcatheter- or surgical valve replacement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Event rate of all cause death
Event rate of cardiac death
Event rate of stroke
Event rate of myocardial infarction
Event rate of rehospitalization
Event rate of infection
Valve related infection or infective endocarditis
Event rate of acute kidney injury
Event rate of vascular complication
Event rate of bleeding
Event rate of device success

Full Information

First Posted
December 30, 2018
Last Updated
January 31, 2019
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03793296
Brief Title
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
Acronym
PVL closure
Official Title
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
At sponsor's discretion
Study Start Date
January 31, 2019 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency
Keywords
Paravalvular leak

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paravalvular leak
Arm Type
Experimental
Arm Description
After transcatheter- or surgical valve replacement
Intervention Type
Device
Intervention Name(s)
Percutaneous Device Closure: Vascular plug
Intervention Description
percutaneous transcatheter approach into cardiac valve
Primary Outcome Measure Information:
Title
Degree of para-valvular leakage
Description
classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Event rate of all cause death
Time Frame
up to 5 years
Title
Event rate of cardiac death
Time Frame
up to 5 years
Title
Event rate of stroke
Time Frame
up to 5 years
Title
Event rate of myocardial infarction
Time Frame
up to 5 years
Title
Event rate of rehospitalization
Time Frame
up to 5 years
Title
Event rate of infection
Description
Valve related infection or infective endocarditis
Time Frame
up to 5 years
Title
Event rate of acute kidney injury
Time Frame
1 month
Title
Event rate of vascular complication
Time Frame
1 month
Title
Event rate of bleeding
Time Frame
1 month
Title
Event rate of device success
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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