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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06597578
Acronym
KOBES
Enrollment
200
Registered
2024-09-19
Start date
2023-06-04
Completion date
2027-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillators, Implantable, Infections, Pacemaker, Artificial

Keywords

lead extraction, cardiac device, infection, complication, pacemaker, implantable cardioverter-defibrillator, extraction tools

Brief 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.

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

DEVICEExtraction tools

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

Sponsors

Evangelic Hospital Kalk Cologne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Procedural success1 weekComplete / partial success with combined femoral superior extraction compared to superior extraction only

Secondary

MeasureTime frameDescription
Complications1 yearPeriprocedural complications

Countries

Germany

Contacts

Primary ContactAnita ceranic
anita.ceranic@evkk.de+492218289
Backup ContactMarkus Kirch, MD
markus.kirch@evkk.de+492218289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026