Clinical trial NCT06597578: Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
Official title: Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infections
Pacemaker, Artificial
Defibrillators, Implantable
Keywords: lead extraction
cardiac device
infection
complication
pacemaker
implantable cardioverter-defibrillator
extraction tools
Lead sponsor: Evangelic Hospital Kalk Cologne
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting at the Koeln Bonn cooperative lead extraction center for a complex lead extraction

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Procedural success
timeFrame: 1 week
Secondary outcomes:
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Köln
country: Germany
facility: EVKK
Study officials:
affiliation: EVKK
name: Frank Eberhardt, MD
role: PRINCIPAL_INVESTIGATOR
References: