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NCT Number: NCT06597578

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Extraction tools

Device

The effect of different extraction tools on outcome parameters will be evaluated

Primary outcomes

  1. Procedural success

    Time frame: 1 week

    Complete / partial success with combined femoral superior extraction compared to superior extraction only

Secondary outcomes

  1. Complications

    Time frame: 1 year

    Periprocedural complications

Study contacts

Contact information is provided by the study sponsor or research team.

Anita ceranic

CONTACT

[email protected]

+492218289 ext. 2200

Markus Kirch, MD

CONTACT

[email protected]

+492218289 ext. 3210

Sponsors and collaborators

Lead sponsor

Evangelic Hospital Kalk Cologne

Other

Registry information

Official study title

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

Acronym: KOBES

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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