Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Premature Ventricular Complex, Scar-related Atrial Tachycardia, Ventricular Tachycardia
Conditions
Brief summary
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
Interventions
DEVICEGlobe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for 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, premature ventricular complex, atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included) * At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, 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 participants 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 participants with ventricular arrhythmia * LVEF \<= 40% for participants with atrial arrhythmia * Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter * 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) * Participants with known untreatable allergy to contrast media * 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 Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s) | Up to 7 days of index procedure on Day 1 | Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported. |
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter | Up to 7 days of index procedure on Day 1 | Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders for Physician Assessment for Pacing | Up to 29 weeks | Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing. |
| Number of Responders for Physician Assessment for Catheter Design | Up to 29 weeks | 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. |
| Number of Responders for Physician Assessment for Workflow | Up to 29 weeks | 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 Responders for Physician Assessment for Catheter Visualization | Up to 29 weeks | 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 Responders for Physician Assessment for Catheters Interactions | Up to 29 weeks | 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 Maneuverability and Handling | Up to 29 weeks | Number of responders for physician assessment for maneuverability & handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling. |
| Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Up to 29 weeks | 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 29 weeks | 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 Ability to Identify Arrhythmia Circuit or Source Correctly | Up to 29 weeks | Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly. |
| Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure | Up to 7 days of index procedure on Day 1 | Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter | Up to 7 days of index procedure on Day 1 | Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. |
| Number of Responders for Physician Assessment for Arrhythmogenicity | Up to 29 weeks | Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity. |
| Number of Responders for Physician Assessment for Signal Collection and Quality | Up to 29 weeks | Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality. |
Countries
Belgium, Croatia, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures, underwent pre-ablation mapping of the chambers of interest using the multi-electrode ECG mapping catheter (investigational catheter) prior to a standard of care ablation procedure. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | — |
|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 15.73 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 25 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 1 / 40 |
| serious Total, serious adverse events | 4 / 40 |
Outcome results
Primary
Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)
Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
Time frame: Up to 7 days of index procedure on Day 1
Population: Per-protocol analysis set included all participants who completed the protocol-required pre-ablation mapping with the investigational catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s) | 40 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter
Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 7 days of index procedure on Day 1
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter | 1 Participants |
Secondary
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter
Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.
Time frame: Up to 7 days of index procedure on Day 1
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter | 1 Participants |
Secondary
Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure
Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 7 days of index procedure on Day 1
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Participants With SAEs Excluding Investigational Catheter Related 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 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 6 | 17 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to the PENTARAY catheter: Score 7 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 4 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 5 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 6 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Characterize the Tissue | Compared to other competitive multielectrode catheters: Score 7 | 1 Participants |
Secondary
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 4 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 5 | 14 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 6 | 18 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to the PENTARAY catheter: Score 7 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 5 | 14 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 6 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly | Compared to other competitive multielectrode catheters: Score 7 | 1 Participants |
Secondary
Number of Responders for Physician Assessment for Arrhythmogenicity
Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 6 | 20 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to the PENTARAY catheter: Score 7 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 5 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 6 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Arrhythmogenicity | Compared to other competitive multielectrode catheters: Score 7 | 4 Participants |
Secondary
Number of Responders for Physician Assessment for Catheter Design
Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 5 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 6 | 22 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Ability to achieve electrode contact with cardiac tissue: Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 6 | 13 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrodes spacing: Score 7 | 13 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 6 | 18 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Design | Electrode array coverage: Score 7 | 8 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 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 1 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 3 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 4 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 6 | 16 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | CARTO 3 System: Score 7 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Electrophysiology (EP) Lab recording equipment: Score 1 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 3 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 5 | 16 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 6 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | EP Lab recording equipment: Score 7 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 5 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 6 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Pacing equipment: Score 7 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 1 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 5 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 6 | 13 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Introducer tool on catheter: Score 7 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 1 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 5 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 6 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Sheath: Score 7 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 1 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 5 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 6 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Irrigation bag and tubing: Score 7 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | Implantable cardioverter-defibrillators (ICD) or other implantable devices: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 4 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 5 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 6 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheters Interactions | ICD or other implantable devices: Score 7 | 0 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 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 2 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 6 | 18 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization under fluoroscopy: Score 7 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 3 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 5 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 6 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Catheter Visualization | Visualization in CARTO 3: Score 7 | 12 Participants |
Secondary
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 5 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 6 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to the PENTARAY catheter: Score 7 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 6 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI) | Compared to other competitive multielectrode catheters: Score 7 | 3 Participants |
Secondary
Number of Responders for Physician Assessment for Maneuverability and Handling
Number of responders for physician assessment for maneuverability & handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 5 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 6 | 14 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Atrium): Score 7 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 5 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 6 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Atrium): Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 4 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 5 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 6 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Left Ventricle): Score 7 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 4 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 5 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 6 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Deploy (Right Ventricle): Score 7 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 5 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 6 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Atrium): Score 7 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 5 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 6 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Atrium): Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 5 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 6 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Left Ventricle): Score 7 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 4 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 5 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 6 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Maneuver (Right Ventricle): Score 7 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 5 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 6 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Atrium): Score 7 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 4 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 5 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 6 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Atrium): Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 5 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 6 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Left Ventricle): Score 7 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 4 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 5 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 6 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to Reach Areas (Right Ventricle): Score 7 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 3 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 5 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 6 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Atrium): Score 7 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 5 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 6 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Atrium): Score 7 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 4 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 5 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 6 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Left Ventricles): Score 7 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 5 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 6 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Ability to withdraw (Right Ventricles): Score 7 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 5 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 6 | 20 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Overall ease of use of the catheter: Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 5 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 6 | 13 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Insertion and withdrawal from introducer sheath: Score 7 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 4 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 5 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 6 | 17 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Maneuverability and Handling | Learning curve: Score 7 | 4 Participants |
Secondary
Number of Responders for Physician Assessment for Pacing
Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 5 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 6 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | High output stimulation pacing: Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 3 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 5 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 6 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Pacing | Local pacing capture: Score 7 | 5 Participants |
Secondary
Number of Responders for Physician Assessment for Signal Collection and Quality
Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality.
Time frame: Up to 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 4 | 3 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 5 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 6 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Atria: Score 7 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 4 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 5 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 6 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR signals in Ventricles: Score 7 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 5 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 6 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | UNIPOLAR noise encountered: Score 7 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 5 | 6 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 6 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Atria: Score 7 | 15 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 4 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 5 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 6 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR signals in Ventricles: Score 7 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 5 | 7 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 6 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BASELINE noise encountered: Score 7 | 14 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 5 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 6 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Signal Collection and Quality | BIPOLAR noise encountered: Score 7 | 15 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 29 weeks
Population: The safety analysis set consisted of all enrolled participants who underwent insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 3 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 4 | 5 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 5 | 14 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 6 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to reduce fluoroscopy: Score 7 | 10 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 5 | 14 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 6 | 19 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for pre-procedure mapping: Score 7 | 2 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 2 | 1 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 5 | 8 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 6 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Time for post-procedure mapping after standard of care ablation: Score 7 | 12 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 1 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 2 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 6 | 9 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 3 | 0 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 4 | 4 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 5 | 11 Participants |
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | Number of Responders for Physician Assessment for Workflow | Ability to identify targets: Score 7 | 5 Participants |