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

Sponsor
Evangelic Hospital Kalk Cologne
Study ID
NCT06597578
Status
Recruiting
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Conditions

  • Defibrillators, Implantable
  • Infections
  • Pacemaker, Artificial

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Extraction tools — DEVICE
    The effect of different extraction tools on outcome parameters will be evaluated

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Jun 4, 2023
Status verified
Feb 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Procedural success [ Time Frame: 1 week ]

Central Contacts

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