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Japanese Lead Extraction Registry (J-LEX)

N

National Cerebral and Cardiovascular Center, Japan

Status

Enrolling

Conditions

Arrhythmia, Cardiac

Study type

Observational

Funder types

Other

Identifiers

NCT04345627
M29-146
UMIN000036078 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing transvenous lead extraction in Japan.

Exclusion criteria

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

Trial contacts and locations

1

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Central trial contact

Misa Takegami, PhD, MPH; Kengo Kusano, MD, PhD

Data sourced from clinicaltrials.gov

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