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Completed

NCT Number: NCT05992623

Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Health System

Falls Church, Virginia, 22042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoll external defibrillator

Device

Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator

Lifepak external defibrillator

Device

Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator

Primary outcomes

  1. The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock

    Time frame: At least 1 minute after shock delivery

    The frequency of NSR by ECG one minute after a single full output DCCV shock is delivered by either a 200J RBW waveform shock from a Zoll Series R defibrillator or 360J BTE waveform shock from a Lifepak 15 defibrillator

Secondary outcomes

  1. The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock

    Time frame: At least 1 minute after shock delivery

    The frequency of NSR by ECG one minute after a first or second full output DCCV shock is delivered using either a 200J RBW waveform shock from a Zoll Series R defibrillator or 360J BTE waveform shock from a Lifepak 15 defibrillator

  2. 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.

    Time frame: At least 1 minute after shock delivery

    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.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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