Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEvangelic Hospital Kalk Cologne
About this trial
The KOBES registry is an all-comers prospective clinical registry of the cooperative Köln Bonn lead extraction center. All patients undergoing complex lead extraction procedures (i.e. indwelling leads \> 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. Preoperative, intraoperative/procedural and postoperative parameters will be recorded. All patients will be asked to provide written informed consent. Data will be pseudonomyzed and entered into a data sheet. Data will be monitored by a board and evaluated independently.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines
Disqualifiers
None
Trial population
All patients presenting at the Koeln Bonn cooperative lead extraction center for a complex lead extraction
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Extraction tools
DeviceThe effect of different extraction tools on outcome parameters will be evaluated
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Procedural success
Complete / partial success with combined femoral superior extraction compared to superior extraction only
Time frame
1 weekSecondary outcomes
1
Complications
Periprocedural complications
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov