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

NCT ID: NCT06597578

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-04
• Study Completion Date: 2027-12-31

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

Conditions

Infections; Pacemaker, Artificial; Defibrillators, Implantable

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Extraction tools

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evangelic Hospital Kalk Cologne

OTHER

Sponsor Role: lead

Responsible Party

Frank Eberhardt

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Eberhardt, MD

Role: PRINCIPAL_INVESTIGATOR

EVKK

Locations

EVKK

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Anita ceranic

Role: CONTACT

anita.ceranic@evkk.de

+492218289 ext. 2200

Markus Kirch, MD

Role: CONTACT

markus.kirch@evkk.de

+492218289 ext. 3210

Facility Contacts

Frank Eberhardt, MD

Role: primary

frank.eberhardt@evkk.de

+49-221-8289 ext. 3201

Markus Kirch, MD

Role: backup

markus.kirch@evkk.de

+49-221-8289 ext. 3211

Other Identifiers

2023KÖB

Identifier Type: -

Identifier Source: org_study_id