Atrial Fibrillation
Conditions
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.
Interventions
DEVICEZoll external defibrillator
Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
DEVICELifepak external defibrillator
Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R 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. | 270 |
| 360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 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. | 276 |
| Total | 546 |
Baseline characteristics
| Characteristic | 200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator | 360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator | Total |
|---|---|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 13.1 | 68.9 years STANDARD_DEVIATION 14.1 | 69.5 years STANDARD_DEVIATION 13.6 |
| Long-standing Persistent AF | 45 Participants | 54 Participants | 99 Participants |
| Paroxysmal AF | 23 Participants | 31 Participants | 54 Participants |
| Persistent AF | 202 Participants | 193 Participants | 395 Participants |
| Prior AF Ablation | 37 Participants | 40 Participants | 77 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 75 Participants | 90 Participants | 165 Participants |
| Sex: Female, Male Male | 195 Participants | 186 Participants | 381 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 270 | 0 / 276 | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 127 / 270 | 122 / 276 | 19 / 24 | 10 / 22 |
| serious Total, serious adverse events | 0 / 270 | 0 / 276 | 0 / 24 | 0 / 22 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator | The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock | 223 Participants |
| 360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator | The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock | 233 Participants |
p-value: 0.565Chi-squared
Secondary
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
Population: 24/270 patients failed two consecutive 200J RBW shocks and were eligible for crossover, 2/24 patients exited the protocol prior to crossover. 28/276 patients failed two consecutive 360J shocks from a Lifepak 15 defibrillator and were eligible for crossover, 4/28 patients exited the protocol prior to crossover. Reasons for exiting protocol prematurely included initial conversion followed by reinitiation of AF within 1 minute and intial misinterpretation of atrial flutter as sinus rhythm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R 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. | 6 Participants |
| 360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 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. | 12 Participants |
p-value: <0.05Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 200J Synchronized Rectilinear Biphasic Waveform (RBW) Shock From Zoll Series R Defibrillator | The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock | 246 Participants |
| 360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator | The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock | 248 Participants |
p-value: 0.617Chi-squared