Japanese Lead Extraction Registry

Arrhythmia, Cardiac Clinical Trial

— J-LEX  

Official title:

Japanese Lead Extraction Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345627
• Other study ID #: M29-146
• Secondary ID: UMIN000036078
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: March 31, 2032

Study information

• Verified date: November 2023
• Source: National Cerebral and Cardiovascular Center, Japan
• Contact: Kengo Kusano, MD, PhD
• Phone: +81-6-6170-1070
• Email: kusanokengo[@]ncvc.go.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 31, 2032
• Est. primary completion date: March 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing transvenous lead extraction in Japan.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arrhythmia, Cardiac
• Arrhythmias, Cardiac

Locations

Country	Name	City	State
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center, Japan

Country where clinical trial is conducted

Japan, 

Outcome

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