Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Scar-related Atrial Tachycardia, Tachycardia, Ventricular, Ventricular Premature Complexes
Conditions
Brief summary
The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
Interventions
DEVICEOPTRELL Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the management of Atrial procedure (Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation) and Ventricular procedures (Ventricular Tachycardia, Premature Ventricular Complex).
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included) * At least one episode of the targeted arrhythmia (ventricular tachycardia, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment * Signed Participant Informed Consent Form (ICF). * Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
* Diagnosed with an arrhythmia requiring epicardial mapping * Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause * Atrial arrhythmias: participants with a left atrial size greater than (\>) 55 millimeters (mm) * Left Ventricular Ejection Fraction (LVEF) less than or equal to (\<=) 25 percent (%) for Ventricular Tachycardia (VT) participants * LVEF \<= 40% for participants with atrial arrhythmia * Documented intracardiac thrombus as detected on imaging * Contraindication to anticoagulation (that is heparin, warfarin, dabigatran) * History of blood clotting or bleeding abnormalities (example hypercoagulable state) * Myocardial infarction within the past 2 months (60 days) * Documented thromboembolic event (including Transient Ischemic Attack \[TIA\]) within the past 12 months (365 days) * Uncontrolled heart failure or New York Heart Association (NYHA) function class IV * Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days) * Implanted with a prosthetic valve * Active illness or active systemic infection or sepsis * Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) * Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention \[PCI\]) * Atrial septal closure within the past 6 weeks (42 days) * Presence of a condition that precludes vascular access * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being * Concurrent enrollment in an investigational study evaluating another device or drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter | Up to 7 days of index procedure at Day 0 | 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. |
| Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters | Up to 72 days | Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders for Physician Assessment for Maneuverability & Handling | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Signal Collection and Quality | Up to 72 days | 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 |
| Number of Responders for Physician Assessment for Pacing | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Workflow | Up to 72 days | 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. |
| Number of Participants With SAEs Within 7 Days of Index Procedure | Up to 7 days of index procedure at Day 0 | 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. |
| Number of Responders for Physician Assessment for Catheters Interactions | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Arrhythmogenicity | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Up to 72 days | 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. |
| Number of Responders for Physician Assessment for Catheter Visualization | Up to 72 days | 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. |
| Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter | Up to 7 days of index procedure at Day 0 | 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. |
Countries
Belgium, Lithuania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | OPTRELL Mapping Catheter | — |
|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 14.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 7 / 31 |
| serious Total, serious adverse events | 3 / 31 |
Outcome results
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.
Time frame: Up to 72 days
Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPTRELL Mapping Catheter | Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters | 31 Participants |
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.
Time frame: Up to 7 days of index procedure at Day 0
Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPTRELL Mapping Catheter | Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter | 0 Participants |
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.
Time frame: Up to 7 days of index procedure at Day 0
Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPTRELL Mapping Catheter | Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter | 0 Participants |
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.
Time frame: Up to 7 days of index procedure at Day 0
Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPTRELL Mapping Catheter | Number of Participants With SAEs Within 7 Days of Index Procedure | 3 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 6 | 16 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter?: Score 7 | 15 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 6 | 25 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters?: Score 7 | 0 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 4 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 5 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 6 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter?: Score 7 | 14 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 5 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 6 | 19 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters?: Score 7 | 1 Participants |
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.
Time frame: Up to 72 days
Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 2 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 4 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 6 | 18 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Ability to achieve electrode contact with cardiac tissue: Score 7 | 8 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 2 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 6 | 13 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrodes spacing: Score 7 | 17 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 2 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 6 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Electrode array coverage: Score 7 | 21 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 5 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 6 | 12 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | With CARTO 3 System: Score 7 | 15 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 5 | 8 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 6 | 12 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 7 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 5 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 6 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 7 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 4 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 5 | 6 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 6 | 14 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 7 | 8 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 4 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 5 | 6 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 6 | 14 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 7 | 8 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 5 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 6 | 15 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 7 | 11 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 6 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 7 | 3 Participants |
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.
Time frame: Up to 72 days
Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 5 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 6 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 7 | 15 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 5 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 6 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 7 | 18 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 4 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 6 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to the PENTARAY catheter?: Score 7 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 4 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 6 | 13 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Compared to other competitive multielectrode catheters?: Score 7 | 4 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 6 | 6 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Atrium): Score 7 | 17 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 6 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 7 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 4 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 5 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 6 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Left Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 6 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 5 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 6 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Atrium): Score 7 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 5 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 7 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 4 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 6 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Left Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricle): Score 3 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricle): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricles): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricle): Score 6 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 4 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 5 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 6 | 12 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 7 | 6 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 6 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Atrium): Score 7 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 3 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 4 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 6 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 6 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Right Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 6 | 8 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Atrium): Score 7 | 15 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 6 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 4 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 6 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Left Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 3 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 5 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 6 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 7 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 4 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 5 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 6 | 18 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Learning Curve: Score 7 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Atrium): Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Deploy (Right Ventricle): Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Maneuver (Right Atrium): Score 6 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Reach Areas (Left Atrium): Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Atrium): Score 7 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 6 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Ability to Withdraw (Right Ventricle): Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Maneuverability & Handling | Insertion/ Withdrawal from Introducer Sheath: Score 4 | 2 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 3 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 5 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 6 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 7 | 3 Participants |
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
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 7 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 5 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atrium: Score 6 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 7 | 15 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 5 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 6 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricle: Score 7 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 5 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 6 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 7 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 6 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atrium: Score 7 | 16 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 4 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 5 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 6 | 7 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricle: Score 7 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 5 | 3 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 6 | 12 Participants |
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.
Time frame: Up to 72 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 4 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 5 | 6 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 6 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 7 | 5 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 4 | 8 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 5 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 6 | 10 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 7 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 4 | 2 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 5 | 4 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 6 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 7 | 9 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 1 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 2 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 3 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 4 | 1 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 5 | 0 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 6 | 13 Participants |
| OPTRELL Mapping Catheter | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 7 | 14 Participants |