| Primary | Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s) | Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported. | Per-protocol analysis set included all participants who completed the protocol-required "pre-ablation mapping" with the investigational catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure on Day 1 | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter | Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure on Day 1 | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Maneuverability and Handling | Number of responders for physician assessment for maneuverability & handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Signal Collection and Quality | Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Pacing | Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Catheter Design | Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Workflow | Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Catheter Visualization | Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Catheters Interactions | Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Arrhythmogenicity | Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 29 weeks | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure | Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure on Day 1 | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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| Secondary | Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter | Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. | The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure on Day 1 | | | | ID | Title | Description |
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| OG000 | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. |
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