Registry for extracting pacemaker and ICD leads
Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)
This study is collecting information from patients who need their pacemaker or ICD leads removed to see how the procedure goes and to make it safer for everyone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evangelic Hospital Kalk Cologne Academic / other |
| Locations | 1 site (Cologne) |
| Trial ID | NCT06597578 on ClinicalTrials.gov |
What this trial studies
The KOBES registry is a prospective clinical registry that collects data from all patients undergoing complex lead extraction procedures at the Köln Bonn lead extraction center. It includes patients with indwelling leads for more than six months and records preoperative, intraoperative, and postoperative parameters. Data will be pseudonymized and monitored by a board for independent evaluation, ensuring comprehensive insights into the outcomes and complications associated with lead extraction. This registry aims to enhance understanding of lead extraction procedures and improve patient safety.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients with a standard indication for lead extraction as per HRS/EHRA guidelines.
Not a fit: Patients who do not require lead extraction or have contraindications for the procedure may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve the safety and effectiveness of lead extraction procedures for patients with cardiac devices.
How similar studies have performed: Other studies have shown success in similar observational registries, indicating the potential for valuable insights from this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines Exclusion Criteria: * None
Where this trial is running
Cologne
- Evkk — Cologne, Germany (Recruiting)
Study contacts
- Principal investigator: Frank Eberhardt, MD — Evkk
- Study coordinator: Anita ceranic
- Email: anita.ceranic@evkk.de
- Phone: +492218289
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.