Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

NCT05992623 | Completed Results FDA Device

• 1 other identifier: U23-04-5042
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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.

  At least 1 minute after shock delivery

Study Arms (4)

Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator

ACTIVE COMPARATOR

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

Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator

ACTIVE COMPARATOR

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

Zoll defibrillator waveform used after unsuccessful second full output shock.

ACTIVE COMPARATOR

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

Lifepak defibrillator waveform used after unsuccessful second full output shock.

ACTIVE COMPARATOR

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

Interventions

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 defibrillator waveform used after unsuccessful second full output shock.; Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) 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

Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator; Zoll defibrillator waveform used after unsuccessful second full output shock.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Health System

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Brett D. Atwater MD
• Organization: Inova Schar Heart and Vascular

brett.atwater@inova.org

9192390127

Study Officials

• Brett Atwater, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 15, 2023
• Study Start: July 21, 2023
• Primary Completion: August 14, 2024
• Study Completion: December 11, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Locations

US (1)