Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597578
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-21
Brief Title:
Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden KÖBES
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOBES
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 ie indwelling leads 6months in the hybrid operating room with cardiothoracic standby will be included in the registry Preoperative intraoperativeprocedural 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 diseaseHTN DM
CRF GFR mlmin
if yes dialysis
anticoagulation antithrombotic therapy JaNein
Indication
infection localsystemic classification
blood culture positivenegative
swab positive
classification
TEE posneg
Device malfunction
Phlebography yn
Vascular access yn
Number of Leads and Type
unibipolar age abandoned leads
ICD-leads single-dual-coil age abandoned leads
Intraoperative
General
type of anaethesia
TEE yn
Safety wire yn
temporary pacing wire yn
Access
Subclavia rlbil
Femoral yn if yes planned Bailout geplant Tools
LLD yn Number
Mechanical sheath and type
Laser sheath
Additional tools Loop-Snare Needle-Eye Snare Rat-Tooth Result extraction complete partial failed
procedural success yn
infection procedural clinial success
Safety lead yn
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
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 diseaseHTN DM
CRF GFR mlmin
if yes dialysis
anticoagulation antithrombotic therapy JaNein
Indication
infection localsystemic classification
blood culture positivenegative
swab positive
classification
TEE posneg
Device malfunction
Phlebography yn
Vascular access yn
Number of Leads and Type
unibipolar age abandoned leads
ICD-leads single-dual-coil age abandoned leads
Intraoperative
General
type of anaethesia
TEE yn
Safety wire yn
temporary pacing wire yn
Access
Subclavia rlbil
Femoral yn if yes planned Bailout geplant Tools
LLD yn Number
Mechanical sheath and type
Laser sheath
Additional tools Loop-Snare Needle-Eye Snare Rat-Tooth Result extraction complete partial failed
procedural success yn
infection procedural clinial success
Safety lead yn
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None