A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inova Health Care Services
- Enrollment
- 546
- Locations
- 1
- Primary Endpoint
- The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Zoll external defibrillator (Device)
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.
Intervention: Lifepak external defibrillator (Device)
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.
Intervention: Lifepak external defibrillator (Device)
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.
Intervention: Zoll external defibrillator (Device)
Outcomes
Primary Outcomes
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
Time Frame: At least 1 minute after shock delivery
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
Secondary Outcomes
- 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)