Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Inova Health Care Services546 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

546

Conditions

Atrial Fibrillation

Interventions

Zoll external defibrillatorDEVICE

Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator

Lifepak external defibrillatorDEVICE

Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Inova Health System

Falls Church, Virginia, United States

Outcomes

Primary Outcomes

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

Time frame: At least 1 minute after shock delivery

Secondary Outcomes

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

Time frame: 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.

Time frame: At least 1 minute after shock delivery

Data from ClinicalTrials.gov

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