InfectionsKOBESNCT06597578
Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
An observational study of Infections and Pacemaker, Artificial, run by Evangelic Hospital Kalk Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Pacemaker, Artificial, Defibrillators, Implantable
- What is being tested?
- Extraction tools
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jun 2023to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting at the Koeln Bonn cooperative lead extraction center for a complex lead extraction
Who may be able to join
- All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
EVKK
Cologne, 51103
Frank Eberhardt, MD, +49-221-8289 ext. 3201, frank.eberhardt@evkk.de
Markus Kirch, MD, +49-221-8289 ext. 3211, markus.kirch@evkk.de
About this study
Official title: 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.
Read the 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
- Being tested
- Extraction tools
- Keywords
- lead extraction, cardiac device, infection, complication, pacemaker, implantable cardioverter-defibrillator, extraction tools
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction toolsDevice
The effect of different extraction tools on outcome parameters will be evaluated
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Complete / partial success with combined femoral superior extraction compared to superior extraction only
Measured: 1 week
Secondary outcomes (1)
Complications
Periprocedural complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Evangelic Hospital Kalk Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Eberhardt, Evangelic Hospital Kalk Cologne
- Investigators
- Frank Eberhardt, MD, Principal investigator, EVKK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597578
- Sponsor's protocol ID
- 2023KÖB
- Acronym
- KOBES
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)
- ClinicalTrials.gov ID
- NCT06597578
- Acronym / sponsor ID
- KOBES / 2023KÖB
- Keywords
- lead extraction, cardiac device, infection, complication, pacemaker, implantable cardioverter-defibrillator, extraction tools
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Evangelic Hospital Kalk CologneUniversity, hospital or other
- Study start
- 4 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting at the Koeln Bonn cooperative lead extraction center for a complex lead extraction
Key inclusion criteria (1 listed)
- All patients with a standard indication for lead extraction according to the HRS / EHRA guidelines
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraction toolsThe effect of different extraction tools on outcome parameters will be evaluated | Device | – |
Primary outcome
Procedural success
Time frame: 1 week
Complete / partial success with combined femoral superior extraction compared to superior extraction only
1 secondary outcome
Complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Eberhardt, MD principal investigator
EVKK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections and Pacemaker, Artificial, run by Evangelic Hospital Kalk Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita ceranic (+492218289 ext. 2200, anita.ceranic@evkk.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.