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

January 31, 2019 updated by: Seung-Jung Park

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paravalvular leak
After transcatheter- or surgical valve replacement
Device: Percutaneous Device Closure: Vascular plug
percutaneous transcatheter approach into cardiac valve

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event rate of all cause death
Time Frame: up to 5 years
up to 5 years
Event rate of cardiac death
Time Frame: up to 5 years
up to 5 years
Event rate of stroke
Time Frame: up to 5 years
up to 5 years
Event rate of myocardial infarction
Time Frame: up to 5 years
up to 5 years
Event rate of rehospitalization
Time Frame: up to 5 years
up to 5 years
Event rate of infection
Time Frame: up to 5 years
Valve related infection or infective endocarditis
up to 5 years
Event rate of acute kidney injury
Time Frame: 1 month
1 month
Event rate of vascular complication
Time Frame: 1 month
1 month
Event rate of bleeding
Time Frame: 1 month
1 month
Event rate of device success
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 31, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

December 30, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2018-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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