Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)

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

Data will be derived from approximately 560 patients arriving to Inova sites of care in Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will be included if they are in AF prior to their procedure and are willing to sign the information sheet and comply with the research procedures. Participants will be excluded if they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.

Inclusion Criteria:

1. Age ≥ 18 years
2. In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area

Exclusion Criteria:

1. Participants who are receiving any other investigational agents.
2. Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
3. Patients with arrhythmias other than AF
4. Patients with hemodynamically unstable AF
5. Patients with untreated hyperthyroidism
6. Patients with known or suspected pregnancy
7. Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi