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

Last updated: September 13, 2024
Sponsor: Evangelic Hospital Kalk Cologne
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Extraction tools

Clinical Study ID

NCT06597578
2023KÖB
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Extraction tools
Phase:
Study Start date:
June 04, 2023
Estimated Completion Date:
December 31, 2027

Study 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

Connect with a study center

  • EVKK

    Köln, 51103
    Germany

    Active - Recruiting

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