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Cologne Cardioversion Study

NCT02241382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-01-26

No results posted yet for this study

Summary

Implantation of internal defibrillators, capable of monitoring the heart and shocking life threatening arrhythmias back to normal rhythm, for patients with severe heart failure increases the probability of survival. Arrhythmias of the atria of the heart are common in these patients. Administering a direct current electrical shock under anesthesia (cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance. Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was demonstrated in several studies. Safety of internal cardioversion (shocking the heart back into normal rhythm via the implanted defibrillator) was described in several smaller trials.

Performing external instead of internal cardioversion in patients with implanted ICDs is more feasible for most hospitals, as CV can be performed without a programming computer and an additional specialist present, e.g. on the intensive care ward, and device interrogation can be done after CV at the remote ICD/pacemaker clinic.

No scientific data on safety and efficacy endpoints comparing internal vs external CV is currently available. The aim of the study is to compare external vs internal electrical cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external and internal cardioversion in large cohort of ICD patients.

Conditions

Interventions

DEVICE

Internal Electrocardioversion

Cardioversion by internal shock application via the implanted ICD

DEVICE

External Electrocardioversion

Cardioversion by external shock application via a cardioverter/defibrillator.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Universitätsklinikum Köln

    lead OTHER

Principal Investigators

  • Daniel Steven, Prof. Dr. · University Hospital Cologne

  • Jakob Lüker, Dr. · University Hospital Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-01-24
Completion
2018-01-24

Countries

  • Australia
  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02241382 on ClinicalTrials.gov