Safety of External Electrocardioversion in Device Patients

• Conditions: Atrial Arrhythmia
• Interventions: Procedure: Cardioversion

• Registration Number: NCT02245009
• Lead Sponsor: Universitätsklinikum Köln

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICD patients	Cardioversion	Patients with ICD, presenting for cardioversion.
Pacemaker patients	Cardioversion	Patients with pacemaker, presenting for cardioversion.
CRT patients	Cardioversion	Patients with CRT device, presenting for cardioversion.

Primary Outcome Measures

Name	Time	Method
Composite safety endpoint: Changes of lead and device parameters	2 weeks after CV	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

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint	within 15 minutes after CV	Assessed by device interrogation and 12-lead ECG: - restoration of normal sinus rhythm after CV
Late changes of lead parameters	2 weeks after CV	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
Inadvertent induction of ventricular fibrillation	10 seconds after CV	Assessed by 3 lead monitoring ECG
Composite endpoint: Early lead changes	within 15 minutes after CV	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
Loss of programming	within 15 minutes after CV	assessed by device interrogation: - loss of programming of the device
Change of shock impedance	within 15 minutes after CV	assessed by device interrogation: - rise in shock impedance by 50%
Change of charge time	within 15 minutes after CV	assessed by device interrogation: - rise in charge time by 50%

Trial Locations

Locations (1)

University Hospital Cologne; 🇩🇪 Cologne, Germany