NCT06597578

Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads

Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Evangelic Hospital Kalk Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Infections
• Pacemaker, Artificial
• Defibrillators, Implantable

Interventions

Type	Name	Description
DEVICE	Extraction tools	The effect of different extraction tools on outcome parameters will be evaluated

Timeline

• Start date: 2023-06-04
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany