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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

Inclusion Criteria:

  • All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines

Exclusion Criteria:

  • None

Study details
    Infections
    Pacemaker
    Artificial
    Defibrillators
    Implantable

NCT06597578

Evangelic Hospital Kalk Cologne

15 October 2025

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