NCT05992623

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Zoll external defibrillator	Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
DEVICE	Lifepak external defibrillator	Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator

Timeline

• Start date: 2023-07-21
• Primary completion: 2024-08-14
• Completion: 2024-12-11
• First posted: 2023-08-15
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study