An observational study in Atrial Arrhythmia, sponsored by Universitätsklinikum Köln. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Universitätsklinikum Köln · Observational
Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators (ICD). External electrical cardioversion is an established method to achieve rhythm control (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices.
The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices.
Introduction Atrial arrhythmias are a common comorbidity in patients with cardiac rhythm management (CRM) devices, such as pacemakers and ICD. External electrical cardioversion is an established method to achieve rhythm control in patients with atrial arrhythmia. A paucity of data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Most publications are of older date and predominantly case reports or case collections. Few prospective studies with a population of cardiac rhythm management patients after external electrical cardioversion have been published in recent years.
Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices.
Rationale Electrocardioversion in Propofol sedation for atrial or ventricular tachyarrhythmia is an established therapy. It is routinely used for patients with cardiac rhythm management devices and the risk of device and lead affectation is deemed to be low. This assumption is currently not supported by substantial and current scientific data, mostly relying on older reports. No large, prospective trials with a population of patients with modern cardiac rhythm management devices exists.
Aim of the study The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices. Thereby, providing reliable evidence and detecting possible SAE with a low incidence. Furthermore, to gather information on efficacy and recurrence rate in this population, to examine the value of external electrical cardioversion for rhythm control in these patients.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Universitätsklinikum Köln is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with implanted cardiac rhythm devices (pacemakers, ICD and CRT)
Exclusion Criteria:
Patients with pacemaker, presenting for cardioversion.
Procedure: Cardioversion
Patients with ICD, presenting for cardioversion.
Procedure: Cardioversion
Patients with CRT device, presenting for cardioversion.
Procedure: Cardioversion
Composite safety endpoint: Changes of lead and device parameters
assessed by device interrogation, if any of the following criteria is met: * a rise in threshold (at constant pulse duration) of \>1V * exit block of any of the pacing leads * loss of programming of the device * rise in shock impedance by 50% * rise in charge time by 50% * drop in battery voltage of ≥0.2V within \< 6 weeks
Time frame: 2 weeks after CV
Efficacy Endpoint
Assessed by device interrogation and 12-lead ECG: - restoration of normal sinus rhythm after CV
Time frame: within 15 minutes after CV
Late changes of lead parameters
Any of the below, assessed by device interrogation: * Lead impedance \> 1000 Ohm * a rise in lead impedance by 50% * ventricular lead sensing \< 2mV * atrial lead sensing \< 1mV
Time frame: 2 weeks after CV
Inadvertent induction of ventricular fibrillation
Assessed by 3 lead monitoring ECG
Time frame: 10 seconds after CV
Composite endpoint: Early lead changes
assessed by device interrogation, if any of the following criteria is met: * a rise in threshold (at constant pulse duration) of \>1V * exit block of any of the pacing leads * Lead impedance \> 1000 Ohm * a rise in lead impedance by 50% * ventricular lead sensing \< 2mV * atrial lead sensing \< 1mV
Time frame: within 15 minutes after CV
Loss of programming
assessed by device interrogation: - loss of programming of the device
Time frame: within 15 minutes after CV
Change of shock impedance
assessed by device interrogation: - rise in shock impedance by 50%
Time frame: within 15 minutes after CV
Change of charge time
assessed by device interrogation: - rise in charge time by 50%
Time frame: within 15 minutes after CV
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Köln