Clinical trial NCT02245009: Safety of External Electrocardioversion in Device Patients
Official title: Safety of External Electrocardioversion in Device Patients - the SEED Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Arrhythmia
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with implanted cardiac rhythm devices (pacemakers, ICD and CRT)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Informed, written consent
* Atrial or ventricular arrhythmia with indication for CV
* Status post CRM implantation, including CRT-D

Exclusion Criteria:

* Age \< 18 years
* Patients under guardianship or with mental disorders / disabilities
* lead implantation \< 4 weeks prior to CV
* contraindications for eCV or transoesophageal echocardiographie (TOE)

Primary outcomes:
measure: Composite safety endpoint: Changes of lead and device parameters
timeFrame: 2 weeks after CV
Secondary outcomes:
measure: Efficacy Endpoint
timeFrame: within 15 minutes after CV
measure: Late changes of lead parameters
timeFrame: 2 weeks after CV
measure: Inadvertent induction of ventricular fibrillation
timeFrame: 10 seconds after CV
measure: Composite endpoint: Early lead changes
timeFrame: within 15 minutes after CV
measure: Loss of programming
timeFrame: within 15 minutes after CV
measure: Change of shock impedance
timeFrame: within 15 minutes after CV
measure: Change of charge time
timeFrame: within 15 minutes after CV
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
Study officials:
affiliation: University Hospital Cologne
name: Jakob Lüker, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Cologne
name: Daniel Steven, Prof. Dr.
role: STUDY_DIRECTOR
References: