Safety of External Electrocardioversion in Device Patients

Atrial Arrhythmia Clinical Trial

— SEED  

Official title:

Safety of External Electrocardioversion in Device Patients - the SEED Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02245009
• Other study ID #: UKK-SEED-2014
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2014
• Last updated: November 3, 2017
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Universitätsklinikum Köln
• Contact: Jakob Lüker, Dr.
• Phone: +49221478
• Email: jakob.lueker[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Arrhythmia

Intervention

Procedure:
• Cardioversion

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy Endpoint	Assessed by device interrogation and 12-lead ECG: - restoration of normal sinus rhythm after CV	within 15 minutes after CV
Secondary	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
Secondary	Inadvertent induction of ventricular fibrillation	Assessed by 3 lead monitoring ECG	10 seconds after CV
Secondary	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
Secondary	Loss of programming	assessed by device interrogation: - loss of programming of the device	within 15 minutes after CV
Secondary	Change of shock impedance	assessed by device interrogation: - rise in shock impedance by 50%	within 15 minutes after CV
Secondary	Change of charge time	assessed by device interrogation: - rise in charge time by 50%	within 15 minutes after CV