Condition category
Circulatory System
Date applied
15/06/2004
Date assigned
31/01/2005
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paulus Kirchhof

ORCID ID

Contact details

Department of Cardiology and Angiology
University Hospital Münster
Albert-Schweitzer-Straße 33
Münster
48129
Germany
+49 (0)251 8347638
kirchhp@uni-muenster.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MOBIPAPA

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Successful restoration of sinus rhythm by the cardioversion shock.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Patients presenting with atrial flutter or atrial tachycardias

Recruitment start date

01/01/2004

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Cardiology and Angiology
Münster
48129
Germany

Sponsor information

Organisation

University Hospital Münster (Germany)

Sponsor details

Albert-Schweitzer-Straße 33
Münster
D-48129
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Münster (Germany) - Department of Cardiology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medtronic Inc (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes