Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Inova Health Care Services

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Zoll external defibrillator; Device: Lifepak external defibrillator

Study type: Interventional

Funder types: Other

Identifiers

NCT05992623

U23-04-5042

Details and patient eligibility

About

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

Full 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.

Enrollment: 546 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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546 participants in 4 patient groups

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

Active Comparator group

Description:

Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.

Treatment:

Device: Zoll external defibrillator

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

Active Comparator group

Description:

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.

Treatment:

Device: Lifepak external defibrillator

Zoll defibrillator waveform used after unsuccessful second full output shock.

Active Comparator group

Description:

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.

Treatment:

Device: Lifepak external defibrillator

Lifepak defibrillator waveform used after unsuccessful second full output shock.

Active Comparator group

Description:

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.

Treatment:

Device: Zoll external defibrillator