N/A
Completed N=546
Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation
Source: ClinicalTrials.gov NCT05992623 ↗Enrolled (actual)
546
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock — 223; 233 Participants — p=0.565
Summary
The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock |
223; 233 | 0.565 |
| SECONDARY The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock |
246; 248 | 0.617 |
| SECONDARY The Frequency of NSR One Minute After the First or Second Full Output DCCV Shock is Delivered by a Zoll Series R RBW Waveform Defibrillator and a Lifepak Series 15/20 BTE Waveform Defibrillator After Crossing Over From the Alternative Defibrillator. |
6; 12 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area
Exclusion Criteria
- Participants who are receiving any other investigational agents.
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients with arrhythmias other than AF
- Patients with hemodynamically unstable AF
- Patients with untreated hyperthyroidism
- Patients with known or suspected pregnancy
- Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi
Data sourced from ClinicalTrials.gov (NCT05992623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.