Japanese Lead Extraction Registry | NCT04345627

Studies
Japanese Lead Extraction Registry

NCT04345627

Sponsor

National Cerebral and Cardiovascular Center, Japan

Status

Recruiting

Last Update Posted

Nov 13, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Arrhythmia, Cardiac

Interventions

Not provided

Countries

Japan

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

ID	Type	Description	Link
UMIN000036078	Other Identifier	UMIN-CTR

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Mar 31, 2032Estimated

Completion Date

Mar 31, 2032Estimated

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 14, 2020Actual

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

Nov 8, 2023

Last Update Posted Date

Nov 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kengo Kusano, Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, National Cerebral and Cardiovascular Center, JapanPrincipal Investigator

Lead Sponsor

National Cerebral and Cardiovascular Center, JapanOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.

Detailed Description

Japanese Lead Extraction (J-LEX) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of procedural success	Procedural success was defined as complete or partial and is identified for each lead extracted.	Through discharge from hospital, approximately up to 2 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Number of in-hospital deaths	All-cause death, cardiovascular death, and procedure-related death	Through discharge from hospital, approximately up to 2 weeks.
Number of patients with procedure-related complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing transvenous lead extraction in Japan.

Exclusion Criteria:

Patients who receive open-chest surgical extraction alone.
Patients who refused to consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Inpatients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kengo Kusano, MD, PhD	Contact	+81-6-6170-1070		kusanokengo@ncvc.go.jp
Misa Takegami, PhD, MPH	Contact	+81-6-6170-1070		takegami@ncvc.go.jp

Overall Officials

Name	Affiliation	Role
Kengo Kusano, MD, PhD	National Cerebral and Cardiovascular Center, Japan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cerebral and Cardiovascular Center	Recruiting	Suita	Osaka	564-8565	Japan

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided