Registry for lead extraction procedures in Japan
Japanese Lead Extraction Registry
This study collects information from patients in Japan who are having lead extraction procedures to see how well they work and what complications might happen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | National Cerebral and Cardiovascular Center, Japan Academic / other |
| Locations | 1 site (Suita, Osaka) |
| Trial ID | NCT04345627 on ClinicalTrials.gov |
What this trial studies
The Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry that collects data on patients undergoing transvenous lead extraction in Japan. Conducted by the Japanese Heart Rhythm Society in collaboration with the National Cerebral and Cardiovascular Center, this registry aims to gather information on the success rates, complications, and patient outcomes associated with lead extraction procedures. Data will be collected prospectively using a Research Electronic Data Capture (REDCap) system, focusing on patient backgrounds, lead characteristics, and procedural details. The findings will help identify predictive factors for outcomes and improve clinical practices in lead extraction.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients in Japan who are undergoing transvenous lead extraction.
Not a fit: Patients who receive open-chest surgical extraction alone or those who refuse to consent will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of lead extraction outcomes and complications, leading to improved patient care and safety.
How similar studies have performed: Other observational registries have shown success in improving clinical outcomes and understanding procedural risks, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Suita, Osaka
- National Cerebral and Cardiovascular Center — Suita, Osaka, Japan (Recruiting)
Study contacts
- Principal investigator: Kengo Kusano, MD, PhD — National Cerebral and Cardiovascular Center, Japan
- Study coordinator: Kengo Kusano, MD, PhD
- Email: kusanokengo@ncvc.go.jp
- Phone: +81-6-6170-1070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.