Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extraction tools.
- Who it may be relevant to
- Registry conditions: Infections, Pacemaker, Artificial, Defibrillators, Implantable. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)
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.
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
Interventions
- Device Extraction tools
The effect of different extraction tools on outcome parameters will be evaluated
Primary outcome measures
- Procedural success [Time frame: 1 week]
Secondary outcome measures (1)
- Complications [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- EVKK — Cologne
Identifiers
NCT: NCT06597578 · 2023KÖB