Japanese Lead Extraction Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04345627

Acronym

J-LEX

Enrollment

5000

Registered

2020-04-14

Start date

2018-07-01

Completion date

2032-03-31

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cardiac

Keywords

Lead extraction, Pacemaker, Defibrillator, Complication, REDCap

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of in-hospital deaths	Through discharge from hospital, approximately up to 2 weeks.	All-cause death, cardiovascular death, and procedure-related death
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.

Countries

Japan

Contacts

Primary ContactKengo Kusano, MD, PhD

kusanokengo@ncvc.go.jp+81-6-6170-1070

Backup ContactMisa Takegami, PhD, MPH

takegami@ncvc.go.jp+81-6-6170-1070

Outcome results