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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Cardiology and Angiology
University Hospital Münster
Albert-Schweitzer-Straße 33
Münster
48129
Germany
| Phone | +49 (0)251 8347638 |
|---|---|
| kirchhp@uni-muenster.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Successful restoration of sinus rhythm by the cardioversion shock. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
48129
Germany
Sponsor information
University Hospital Münster (Germany)
Hospital/treatment centre
Hospital/treatment centre
Albert-Schweitzer-Straße 33
Münster
D-48129
Germany
"ROR" |
https://ror.org/01856cw59 |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospital Münster (Germany) - Department of Cardiology
No information available
Medtronic Inc (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
