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Japanese Lead Extraction Registry (J-LEX)

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ClinicalTrials.gov Identifier: NCT04345627
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Kengo Kusano, National Cerebral and Cardiovascular Center

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.

Condition or disease
Arrhythmia, Cardiac

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Japanese Lead Extraction Registry
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : March 31, 2032
Estimated Study Completion Date : March 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345627


Contacts
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Contact: Kengo Kusano, MD, PhD +81-6-6170-1070 kusanokengo@ncvc.go.jp
Contact: Misa Takegami, PhD, MPH +81-6-6170-1070 takegami@ncvc.go.jp

Locations
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Japan
National Cerebral and Cardiovascular Center Recruiting
Suita, Osaka, Japan, 564-8565
Contact: Kengo Kusano, MD, PhD    +81-6-6170-1070    kusanokengo@ncvc.go.jp   
Contact: Misa Takegami, PhD, MPH    +81-6-6170-1070    takegami@ncvc.go.jp   
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Investigators
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Principal Investigator: Kengo Kusano, MD, PhD National Cerebral and Cardiovascular Center
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Responsible Party: Kengo Kusano, Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT04345627    
Other Study ID Numbers: M29-146
UMIN000036078 ( Other Identifier: UMIN-CTR )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kengo Kusano, National Cerebral and Cardiovascular Center:
Lead extraction
Pacemaker
Defibrillator
Complication
REDCap
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes