Safety of External Electrocardioversion in Device Patients (SEED)

Safety of External Electrocardioversion in Device Patients - the SEED Registry

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Arrhythmia
• Intervention / Treatment: Procedure: Cardioversion

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University Hospital Cologne
    • Contact: Daniel Steven, Prof. Dr.; Phone Number: 32396 +49221478; Email: daniel.steven@uk-koeln.de
    • Principal Investigator: Jakob Lüker, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with implanted cardiac rhythm devices (pacemakers, ICD and CRT)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pacemaker patients; Patients with pacemaker, presenting for cardioversion.	Procedure: Cardioversion
ICD patients; Patients with ICD, presenting for cardioversion.	Procedure: Cardioversion
CRT patients; Patients with CRT device, presenting for cardioversion.	Procedure: Cardioversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks after CV

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint	Assessed by device interrogation and 12-lead ECG: - restoration of normal sinus rhythm after CV	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	2 weeks after CV
Inadvertent induction of ventricular fibrillation	Assessed by 3 lead monitoring ECG	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	within 15 minutes after CV
Loss of programming	assessed by device interrogation: - loss of programming of the device	within 15 minutes after CV
Change of shock impedance	assessed by device interrogation: - rise in shock impedance by 50%	within 15 minutes after CV
Change of charge time	assessed by device interrogation: - rise in charge time by 50%	within 15 minutes after CV

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Investigators: Principal Investigator: Jakob Lüker, Dr., University Hospital Cologne; Study Director: Daniel Steven, Prof. Dr., University Hospital Cologne

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: UKK-SEED-2014