Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Lifepak external defibrillator; Device: Zoll external defibrillator

• Registration Number: NCT05992623
• Lead Sponsor: Inova Health Care Services

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

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 Timeline

• Study Start: 2023-07-21
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-15
• Primary Completion: 2024-08-14
• Status Verified: 2024-12
• Study Completion: 2024-12-11
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zoll defibrillator waveform used after unsuccessful second full output shock.	Lifepak external defibrillator	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.
Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator	Lifepak external 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.
Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator	Zoll external 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.
Lifepak defibrillator waveform used after unsuccessful second full output shock.	Zoll external defibrillator	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.

Primary Outcome Measures

Name	Time	Method
The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock	Up to 1 minute after shock delivered	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

Trial Locations

Locations (1)

Inova Health System; 🇺🇸 Falls Church, Virginia, United States