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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Zoll external defibrillator; Device: Lifepak external defibrillator

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.

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator; 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; Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
Active Comparator: Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator; 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; Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator
Active Comparator: Zoll defibrillator waveform used after unsuccessful second full output shock.; 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; Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator
Active Comparator: Lifepak defibrillator waveform used after unsuccessful second full output shock.; 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; Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator

What is the study measuring?

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 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	At least 1 minute after shock delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock	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	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.	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.	At least 1 minute after shock delivery

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Brett Atwater, MD, Inova Health Care Services

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): August 14, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: U23-04-5042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No