Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Zoll external defibrillator
* Device: Lifepak external defibrillator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to a Zoll or Lifepak defibrillator to perform the DCCV. All shocks will be full output (200J for Zoll shocks and 360J for Lifepak shocks). Follow up will be assessment and documentation of rhythm 1 minute after the last shock is delivered. Participants who do not have first shock success will have a second full output shock ≥1 minute after the first shock. Participants who do not have success after a second full output shock will be crossed over to the other defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator<br>Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks. | Device: Zoll external defibrillator<br>* Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator<br>|
| Active Comparator: Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator<br>Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks. | Device: Lifepak external defibrillator<br>* Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator<br>|
| Active Comparator: Zoll defibrillator waveform used after unsuccessful second full output shock.<br>Participants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock. | Device: Lifepak external defibrillator<br>* Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator<br>|
| Active Comparator: Lifepak defibrillator waveform used after unsuccessful second full output shock.<br>Participants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock. | Device: Zoll external defibrillator<br>* Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock | The frequency of NSR one minute, identified by ECG, after a single full output DCCV shock is delivered by either a Zoll RBW waveform defibrillator or Lifepak BTE waveform defibrillator | Up to 1 minute after shock delivered |