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Safety of External Electrocardioversion in Device Patients (SEED)

3. november 2017 oppdatert av: Universitätsklinikum Köln

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Cologne, Tyskland, 50937
        • Rekruttering
        • University Hospital Cologne
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jakob Lüker, Dr.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Pacemaker patients
Patients with pacemaker, presenting for cardioversion.
ICD patients
Patients with ICD, presenting for cardioversion.
CRT patients
Patients with CRT device, presenting for cardioversion.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite safety endpoint: Changes of lead and device parameters
Tidsramme: 2 weeks after CV

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Efficacy Endpoint
Tidsramme: within 15 minutes after CV

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
Tidsramme: 2 weeks after CV

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
Tidsramme: 10 seconds after CV
Assessed by 3 lead monitoring ECG
10 seconds after CV
Composite endpoint: Early lead changes
Tidsramme: within 15 minutes after CV

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
Tidsramme: within 15 minutes after CV

assessed by device interrogation:

- loss of programming of the device

within 15 minutes after CV
Change of shock impedance
Tidsramme: within 15 minutes after CV

assessed by device interrogation:

- rise in shock impedance by 50%

within 15 minutes after CV
Change of charge time
Tidsramme: within 15 minutes after CV

assessed by device interrogation:

- rise in charge time by 50%

within 15 minutes after CV

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jakob Lüker, Dr., University Hospital Cologne
  • Studieleder: Daniel Steven, Prof. Dr., University Hospital Cologne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2014

Primær fullføring (Forventet)

1. november 2018

Studiet fullført (Forventet)

1. desember 2018

Datoer for studieregistrering

Først innsendt

5. september 2014

Først innsendt som oppfylte QC-kriteriene

16. september 2014

Først lagt ut (Anslag)

19. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2017

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • UKK-SEED-2014

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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