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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Cologne, Německo, 50937
- Nábor
- University Hospital Cologne
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Kontakt:
- Daniel Steven, Prof. Dr.
- Telefonní číslo: 32396 +49221478
- E-mail: daniel.steven@uk-koeln.de
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Vrchní vyšetřovatel:
- Jakob Lüker, Dr.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Composite safety endpoint: Changes of lead and device parameters
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Efficacy Endpoint
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jakob Lüker, Dr., University Hospital Cologne
- Ředitel studie: Daniel Steven, Prof. Dr., University Hospital Cologne
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UKK-SEED-2014
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