NCT06597578

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jun 2023Dec 2027

Study Start

First participant enrolled

June 4, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 19, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

February 21, 2024

Last Update Submit

September 13, 2024

Conditions

InfectionsPacemaker, ArtificialDefibrillators, Implantable

Keywords

lead extractioncardiac deviceinfectioncomplicationpacemakerimplantable cardioverter-defibrillatorextraction tools

Outcome Measures

Primary Outcomes (1)

  • Procedural success

    Complete / partial success with combined femoral superior extraction compared to superior extraction only

    1 week

Secondary Outcomes (1)

  • Complications

    1 year

Interventions

Extraction toolsDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EVKK

Cologne, 51103, Germany

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

  • Frank Eberhardt, MD

    EVKK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita ceranic

CONTACT

+492218289anita.ceranic@evkk.de

Markus Kirch, MD

CONTACT

+492218289markus.kirch@evkk.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2024

First Posted

September 19, 2024

Study Start

June 4, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 19, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)