NCT04345627

Japanese Lead Extraction Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: National Cerebral and Cardiovascular Center, Japan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia, Cardiac

Timeline

• Start date: 2018-07-01
• Primary completion: 2032-03-31
• Completion: 2032-03-31
• First posted: 2020-04-14
• Last updated: 2023-11-13

Locations

1 site across 1 country: Japan