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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Defibrillators, Implantable; Pacemaker, Artificial
• Intervention / Treatment: Device: Extraction tools

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Anita ceranic; Phone Number: 2200 +492218289; Email: anita.ceranic@evkk.de
• Study Contact Backup: Name: Markus Kirch, MD; Phone Number: 3210 +492218289; Email: markus.kirch@evkk.de

Study Locations

• Germany
  • Köln, Germany, 51103
    • Recruiting
    • EVKK
    • Contact: Frank Eberhardt, MD; Phone Number: 3201 +49-221-8289; Email: frank.eberhardt@evkk.de
    • Contact: Markus Kirch, MD; Phone Number: 3211 +49-221-8289; Email: markus.kirch@evkk.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting at the Koeln Bonn cooperative lead extraction center for a complex lead extraction

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Complete / partial success with combined femoral superior extraction compared to superior extraction only	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Periprocedural complications	1 year

Collaborators and Investigators

• Sponsor: Evangelic Hospital Kalk Cologne
• Investigators: Principal Investigator: Frank Eberhardt, MD, EVKK

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: infection; pacemaker; complication; implantable cardioverter-defibrillator; cardiac device; lead extraction; extraction tools
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2023KÖB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No