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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Cologne, Germania, 50937
- Reclutamento
- University Hospital Cologne
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Contatto:
- Daniel Steven, Prof. Dr.
- Numero di telefono: 32396 +49221478
- Email: daniel.steven@uk-koeln.de
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Investigatore principale:
- Jakob Lüker, Dr.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Pacemaker patients
Patients with pacemaker, presenting for cardioversion.
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ICD patients
Patients with ICD, presenting for cardioversion.
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CRT patients
Patients with CRT device, presenting for cardioversion.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite safety endpoint: Changes of lead and device parameters
Lasso di tempo: 2 weeks after CV
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assessed by device interrogation, if any of the following criteria is met:
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2 weeks after CV
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Efficacy Endpoint
Lasso di tempo: within 15 minutes after CV
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Assessed by device interrogation and 12-lead ECG: - restoration of normal sinus rhythm after CV |
within 15 minutes after CV
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Late changes of lead parameters
Lasso di tempo: 2 weeks after CV
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Any of the below, assessed by device interrogation:
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2 weeks after CV
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Inadvertent induction of ventricular fibrillation
Lasso di tempo: 10 seconds after CV
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Assessed by 3 lead monitoring ECG
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10 seconds after CV
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Composite endpoint: Early lead changes
Lasso di tempo: within 15 minutes after CV
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assessed by device interrogation, if any of the following criteria is met:
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within 15 minutes after CV
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Loss of programming
Lasso di tempo: within 15 minutes after CV
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assessed by device interrogation: - loss of programming of the device |
within 15 minutes after CV
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Change of shock impedance
Lasso di tempo: within 15 minutes after CV
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assessed by device interrogation: - rise in shock impedance by 50% |
within 15 minutes after CV
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Change of charge time
Lasso di tempo: within 15 minutes after CV
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assessed by device interrogation: - rise in charge time by 50% |
within 15 minutes after CV
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jakob Lüker, Dr., University Hospital Cologne
- Direttore dello studio: Daniel Steven, Prof. Dr., University Hospital Cologne
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UKK-SEED-2014
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