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NCT Number: NCT04345627

Japanese Lead Extraction Registry

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.

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Key information

Conditions

Arrhythmia, Cardiac Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing transvenous lead extraction in Japan.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Proportion of procedural success

    Time frame: 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 outcomes

  1. Number of in-hospital deaths

    Time frame: Through discharge from hospital, approximately up to 2 weeks.

    All-cause death, cardiovascular death, and procedure-related death

  2. Number of patients with procedure-related complications

    Time frame: 4 weeks

    Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Kengo Kusano, MD, PhD

CONTACT

[email protected]

+81-6-6170-1070

Misa Takegami, PhD, MPH

CONTACT

[email protected]

+81-6-6170-1070

Sponsors and collaborators

Lead sponsor

National Cerebral and Cardiovascular Center, Japan

Other

Registry information

Acronym: J-LEX

Important dates

Study start
2018
Primary completion
2032
Study completion
2032
First posted
Apr 14, 2020
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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