| Primary | Percentage of Subjects With One-year Success | Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | the end of the 3-month blanking period to 12 months following a single ablation procedure | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Kaplan Meier Survival Estimate | 57.2 | Standard Error of the Mean | 3.0 | 2-Sided | 95 | 51.2 | 62.8 | | | Kaplan-Meier estimate of freedom from recurrence after removal from AAD at one year. | | Other | | |
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| Other Pre-specified | Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy | Percentage of participants with freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia rafter removal from AADs. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables. | | Posted | | Number | | percentage of participants | | the end of the 3-month blanking period to 12 months after initial ablation procedure | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Percentage of Subjects With Single Procedure Clinical Success | Single procedure clinical success was defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables. | | Posted | | Number | | percentage of participants | | the end of the 3-month blanking period to 12 months following the initial ablation procedure | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Percentage of Subjects With Freedom From AF/AFL/AT | Freedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables. | | Posted | | Number | | percentage of participants | | the end of the 3-month blanking period to 12 months following the initial ablation procedure | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Number of Subjects With Acute Procedural Success | Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates. | | Posted | | Count of Participants | | Participants | | During procedure, an average of 160 minutes | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Number of Subjects With Arrhythmia Recurrence | Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates. | Subjects with repeat electrophysiology studies in which treatment other than ablation of isthmus dependent atrial flutter was performed. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Left Atrium (LA) Information: LA Volume (LAV) | LA volume will be summarized with the mean with standard deviation. | Number of subjects in which LAV was measured. | Posted | | Mean | Standard Deviation | mL | | Baseline | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Left Atrium (LA) Information: LA Diameter (LAD) | LA diameter will be summarized with the mean with standard deviation. | Includes subjects in which LAD was measured | Posted | | Mean | Standard Deviation | mm | | Baseline | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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| Other Pre-specified | Reportable Adverse Events | Number of adverse events, including any device-, procedure-, or death-related events (serious or non-serious). | | Posted | | Number | | events | | 12 months | | | | ID | Title | Description |
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| OG000 | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter. A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. |
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