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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator | Active Comparator | Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks. |
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| Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator | Active Comparator | 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. |
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| Zoll defibrillator waveform used after unsuccessful second full output shock. | Active Comparator | 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. |
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| Lifepak defibrillator waveform used after unsuccessful second full output shock. | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoll external defibrillator | Device | Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At least 1 minute after shock delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At least 1 minute after shock delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Atwater, MD | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Health System | Falls Church | Virginia | 22042 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 360J Synchronized Biphasic Truncated Exponential Waveform (BTE) Shock From Lifepak 15 Defibrillator |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | At least 1 minute after shock delivery |
|
10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett D. Atwater MD | Inova Schar Heart and Vascular | 9192390127 | brett.atwater@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2023 | Jul 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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.
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| Lifepak external defibrillator | Device | Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak 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. | 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 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Paroxysmal AF | Number | Participants |
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| Persistent AF | Count of Participants | Participants |
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| Long-standing Persistent AF | Count of Participants | Participants |
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| Prior AF Ablation | Count of Participants | Participants |
|
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) |
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| 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 | Posted | Count of Participants | Participants | At least 1 minute after shock delivery |
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| 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. | 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. | Posted | Count of Participants | Participants | At least 1 minute after shock delivery |
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| 0 |
| 270 |
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| 270 |
| 127 |
| 270 |
| EG001 | 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) | 0 | 276 | 0 | 276 | 122 | 276 |
| EG002 | Crossover to 200J RBW Shock After Failed 360J BTE Shock | Participants crossing over to a full output 200J RBW shock from a Zoll defibrillator after 2 failed full output 360J BTE shocks from a Lifepak defibrillator | 0 | 24 | 0 | 24 | 19 | 24 |
| EG003 | Crossover to 360J BTE Shock After Failed 200J RBW Shock | Participants crossing over to a full output 360J BTE shock from a Lifepak defibrillator after 2 failed full output 200J RBW shocks from a Zoll defibrillator | 0 | 22 | 0 | 22 | 10 | 22 |
| Bradycardia/Atriventricular block/ASystole | Cardiac disorders | Systematic Assessment |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |