Japanese Lead Extraction Registry

NCT ID: NCT04345627

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2032-03-31

Brief Summary

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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

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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.

Conditions

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Arrhythmia, Cardiac

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing transvenous lead extraction in Japan.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role lead

Responsible Party

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Kengo Kusano

Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kengo Kusano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cerebral and Cardiovascular Center, Japan

Locations

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National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Kengo Kusano, MD, PhD

Role: CONTACT

+81-6-6170-1070

Misa Takegami, PhD, MPH

Role: CONTACT

+81-6-6170-1070

Facility Contacts

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Kengo Kusano, MD, PhD

Role: primary

+81-6-6170-1070

Misa Takegami, PhD, MPH

Role: backup

+81-6-6170-1070

Other Identifiers

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UMIN000036078

Identifier Type: OTHER

Identifier Source: secondary_id

M29-146

Identifier Type: -

Identifier Source: org_study_id

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