Effects of hand-held paddle electrodes and biphasic shocks on the outcome of external cardioversion of atrial fibrillation

ISRCTN	ISRCTN42858989
DOI	https://doi.org/10.1186/ISRCTN42858989
Protocol serial number	N/A
Sponsor	University Hospital Münster (Germany)
Funders	University Hospital Münster (Germany) - Department of Cardiology, Medtronic Inc (Germany)

Submission date: 15/06/2004
Registration date: 31/01/2005
Last edited: 05/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paulus Kirchhof
Scientific

Department of Cardiology and Angiology
University Hospital Münster
Albert-Schweitzer-Straße 33
Münster
48129
Germany

Phone	+49 (0)251 8347638
Email	kirchhp@uni-muenster.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MOBIPAPA
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Atrial fibrillation
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Successful restoration of sinus rhythm by the cardioversion shock.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	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.
Key exclusion criteria	Patients presenting with atrial flutter or atrial tachycardias
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2005

Locations

Countries of recruitment

Germany

Study participating centre

Department of Cardiology and Angiology

Münster
48129
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan