Japanese Lead Extraction Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Arrhythmia, Cardiac. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Proportion of procedural success [Time frame: Through discharge from hospital, approximately up to 2 weeks.]
Secondary outcome measures (2)
- Number of in-hospital deaths [Time frame: Through discharge from hospital, approximately up to 2 weeks.]
- Number of patients with procedure-related complications [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- Patients undergoing transvenous lead extraction in Japan.
Exclusion criteria
- Patients who receive open-chest surgical extraction alone.
- Patients who refused to consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Japan · 1 center
- National Cerebral and Cardiovascular Center — Suita
Identifiers
NCT: NCT04345627 · M29-146 · UMIN000036078