NCT04345627

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
71mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Jul 2018Mar 2032

Study Start

First participant enrolled

July 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2032

Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

13.8 years

First QC Date

April 10, 2020

Last Update Submit

November 8, 2023

Conditions

Arrhythmia, Cardiac

Keywords

Lead extractionPacemakerDefibrillatorComplicationREDCap

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Number of in-hospital deaths

    Through discharge from hospital, approximately up to 2 weeks.

  • Number of patients with procedure-related complications

    4 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients

You may qualify if:

  • Patients undergoing transvenous lead extraction in Japan.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cerebral and Cardiovascular Center

Suita, Osaka, 564-8565, Japan

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kengo Kusano, MD, PhD

    National Cerebral and Cardiovascular Center, Japan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kengo Kusano, MD, PhD

CONTACT

+81-6-6170-1070kusanokengo@ncvc.go.jp

Misa Takegami, PhD, MPH

CONTACT

+81-6-6170-1070takegami@ncvc.go.jp

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 14, 2020

Study Start

July 1, 2018

Primary Completion (Estimated)

March 31, 2032

Study Completion (Estimated)

March 31, 2032

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

JP(1)