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Safety of External Electrocardioversion in Device Patients

NCT ID: NCT02245009

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Atrial Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pacemaker patients

Patients with pacemaker, presenting for cardioversion.

Cardioversion

Intervention Type PROCEDURE

ICD patients

Patients with ICD, presenting for cardioversion.

Cardioversion

Intervention Type PROCEDURE

CRT patients

Patients with CRT device, presenting for cardioversion.

Cardioversion

Intervention Type PROCEDURE

Interventions

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Cardioversion

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Köln

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakob Lüker, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cologne

Daniel Steven, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Cologne

Locations

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University Hospital Cologne

Cologne, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jakob Lüker, Dr.

Role: CONTACT

Phone: +49221478

Email: [email protected]

Facility Contacts

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Daniel Steven, Prof. Dr.

Role: primary

Other Identifiers

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UKK-SEED-2014

Identifier Type: -

Identifier Source: org_study_id