Percutaneous Device Closure for Significant Paravalvular... | NCT03793296

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

NCT03793296

Sponsor

Seung-Jung Park

Status

Withdrawn

Last Update Posted

Feb 1, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cardiac Valves
Heart Valve Diseases
Valvular Insufficiency

Interventions

Percutaneous Device Closure: Vascular plug

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

At sponsor's discretion

Expanded Access Info

Start Date

Jan 31, 2019Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 30, 2018

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2019

Last Update Posted Date

Feb 1, 2019Actual

Name	Class
CardioVascular Research Foundation, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paravalvular leak	Experimental	After transcatheter- or surgical valve replacement	Device: Percutaneous Device Closure: Vascular plug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous Device Closure: Vascular plug	Device	percutaneous transcatheter approach into cardiac valve	Paravalvular leak

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Event rate of all cause death		up to 5 years
Event rate of cardiac death		up to 5 years
Event rate of stroke

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases