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ISRCTN
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ISRCTN42858989
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ClinicalTrials.gov identifier
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Public title
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Effects of hand-held paddle electrodes and biphasic shocks on the outcome of external cardioversion of atrial fibrillation
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Scientific title
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Acronym
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MOBIPAPA
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Serial number at source
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N/A
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Study hypothesis
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A randomised trial to assess the effects of biphasic shocks in combination with an anterior-posterior electrode position and the effect of hand-held shock electrodes on external electrical cardioversion outcome.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Atrial fibrillation
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Participants - inclusion criteria
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All patients presenting with persistent atrial fibrillation and an indication for external cardioversion in the Department of Cardiology of the University Hospital Münster, Germany were consecutively screened for the trial.
Inclusion criteria:
1. A clinical indication for external cardioversion of atrial fibrillation
2. Documented atrial fibrillation prior to the procedure
3. To minimise thrombo-embolic complications, documented oral anticoagulation with phenprocoumon (international normalised ratio [INR] 2 - 3) for three weeks or exclusion of left atrial thrombi by trans-oesophageal echocardiography directly prior to the cardioversion procedure was required. Continuation of anticoagulation after cardioversion was recommended for all trial patients.
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Participants - exclusion criteria
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Patients presenting with atrial flutter or atrial tachycardias
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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With an assumed success rate of the monophasic shock wave form between 79% and 90%, we calculated a group size of 100 patients per group to achieve a statistical power of 0.8 (beta error 0.2) and a two-sided alpha level of 0.05 for each of the two hypotheses.
All shocks were delivered in an anterior-posterior electrode position. Patients were anaesthetised using standard procedures (either propofol or etomidate in combination with opioid analgetics). The trial was designed to detect an absolute difference in cardioversion success rate of 10% between two different shock wave forms (monophasic/biphasic) and between two different electrode types (hand-held paddle electrodes/adhesive patch electrodes).
Due to training-dependent quality of the positioning of the cardioversion electrodes, a sequential design for the comparison of patch and paddle electrodes was chosen, while the simple exchange of the monophasic and biphasic defibrillators was tested in a randomised design.
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Primary outcome measure(s)
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Successful restoration of sinus rhythm by the cardioversion shock.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. University Hospital Münster (Germany) - Department of Cardiology
2. Medtronic Inc (Germany)
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Trial website
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Publications
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Contact name
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Dr
Paulus
Kirchhof
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Address
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Department of Cardiology and Angiology
University Hospital Münster
Albert-Schweitzer-Straße 33
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City/town
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Münster
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Zip/Postcode
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48129
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Country
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Germany
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Tel
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+49 (0)251 8347638
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Fax
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+49 (0)251 8347864
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Email
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kirchhp@uni-muenster.de
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Sponsor
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University Hospital Münster (Germany)
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Address
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Albert-Schweitzer-Straße 33
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City/town
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Münster
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Zip/Postcode
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D-48129
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Country
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Germany
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Date applied
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15/06/2004
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Last edited
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05/11/2008
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Date ISRCTN assigned
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31/01/2005
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