Japanese Lead Extraction Registry (J-LEX)

April 5, 2022 updated by: Kengo Kusano, National Cerebral and Cardiovascular Center
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • National Cerebral and Cardiovascular Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through discharge from hospital, approximately up to 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through discharge from hospital, approximately up to 2 weeks.
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center

Investigators

  • Principal Investigator: Kengo Kusano, MD, PhD, National Cerebral and Cardiovascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

March 31, 2032

Study Completion (Anticipated)

March 31, 2032

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M29-146
  • UMIN000036078 (Other Identifier: UMIN-CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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