| Primary | Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter | Number of participants with SAEs within 7 days of index procedure related to the OPTRELL 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 had undergone insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters | Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported. | The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Participants With SAEs Within 7 Days of Index Procedure | Number of participants with SAEs 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 had undergone insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter | Number of participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 7 days of index procedure at Day 0 | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Responders for Physician Assessment for Maneuverability & 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 & handling. | The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Responders for Physician Assessment for Signal Collection and Quality | Number of responders for physician assessment for signal collection and quality 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 had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Responders for Physician Assessment for Pacing | Number of responders for physician assessment for pacing (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 had undergone 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 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | 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 in OPTRELL catheter for mapping. | The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| 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 had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| 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 had undergone insertion of the study catheter. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| 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 had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Responders for Physician Assessment for Arrhythmogenicity | Number of responders with 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 had undergone insertion of the study catheter. Here, 'n' (number analyzed) signifies number of participants evaluable at specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| Secondary | Number of Responders for Physician Assessment for Design and Coverage for Confirming 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 had undergone insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |
| 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 had undergone insertion of the study catheter. Here, 'n' (number analyzed) signifies number of participants evaluable at specified categories. | Posted | | Count of Participants | | Participants | | Up to 72 days | | | | ID | Title | Description |
|---|
| OG000 | OPTRELL Mapping 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 used multi-electrode OPTRELL mapping catheter for pre-ablation mapping. |
| |