Japanese Lead Extraction Registry

Recruiting

• Conditions: Arrhythmia, Cardiac

• Registration Number: NCT04345627
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2032-03-31
• Study Completion: 2032-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients undergoing transvenous lead extraction in Japan.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of patients with procedure-related complications	4 weeks	Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.
Number of in-hospital deaths	Through discharge from hospital, approximately up to 2 weeks.	All-cause death, cardiovascular death, and procedure-related death

Trial Locations

Locations (1)

National Cerebral and Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan