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Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)
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.
The following parameters will be included in the registry Preoperative General: * pacemaker / ICD indication * Ejektionsfraktion * previous cardiac surgery / TAVR * specific cardiac disease: IHD, CMP (DCM, HCM, andere), Primary electrical disease if ICD: * primary / secondary prevention concomitant disease:HTN, DM * CRF; GFR (ml/min) * if yes: dialysis ? * anticoagulation / antithrombotic therapy: Ja/Nein Indication: * infection (local/systemic), classification * blood culture positive/negative * swab positive * classification * TEE: pos/neg * Device malfunction * Phlebography y/n * Vascular access y/n * Number of Leads and Type * uni/bipolar / age / abandoned leads * ICD-leads: single-/dual-coil, age / abandoned leads Intraoperative: General: * type of anaethesia * TEE y/n * Safety wire y/n * temporary pacing wire y/n Access: * Subclavia r/l/bil * Femoral: y/n; if yes: planned / Bailout: geplant Tools * LLD: y/n; Number * Mechanical sheath and type * Laser sheath * Additional tools: Loop-Snare / Needle-Eye Snare / Rat-Tooth Result : extraction: complete / partial / failed * procedural success: y/n * infection: procedural / clinial success * Safety lead y/n * temporary pacing wire in situ Intraoperative complications * vascular injury * pericardial effusion / tamponade * pericardiocentesis * occlusion ballon * thoracotomy * Intraoperative catecholamines * death Postoperative: * duration * hospital stay * postoperative active system * transvenous / epicardial / capsule/ subcutaneous / extravascular * type of pacemaker * type of ICD * Wenn ja: transvenös / subkutan Postoperative complications: * hematoma / seroma / fistula * further interventions: Revision / hematoma/ reinfection
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
EVKK
Cologne, Germany
Start Date
June 4, 2023
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2027
Last Updated
September 19, 2024
200
ESTIMATED participants
Extraction tools
DEVICE
Lead Sponsor
Evangelic Hospital Kalk Cologne
NCT05488340
NCT06237452
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287