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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN42858989
Enrollment
200
Registered
2005-01-31
Start date
2004-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System Atrial fibrillation

Interventions

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 tw

Sponsors

University Hospital Münster (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Patients presenting with atrial flutter or atrial tachycardias

Design outcomes

Primary

MeasureTime frame
Successful restoration of sinus rhythm by the cardioversion shock.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026