A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter

Study Overview
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Brief Summary
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The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.

Official Title
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Clinical Evaluation of Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter

Conditions
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Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Tachycardia, Ventricular, Ventricular Premature Complexes

Intervention / Treatment
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* Device: OPTRELL Mapping Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included) At least one episode of the targeted arrhythmia (ventricular tachycardia, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment Signed Participant Informed Consent Form (ICF). Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: Diagnosed with an arrhythmia requiring epicardial mapping Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause Atrial arrhythmias: participants with a left atrial size greater than (>) 55 millimeters (mm) Left Ventricular Ejection Fraction (LVEF) less than or equal to (<=) 25 percent (%) for Ventricular Tachycardia (VT) participants LVEF <= 40% for participants with atrial arrhythmia Documented intracardiac thrombus as detected on imaging Contraindication to anticoagulation (that is heparin, warfarin, dabigatran) History of blood clotting or bleeding abnormalities (example hypercoagulable state) Myocardial infarction within the past 2 months (60 days) Documented thromboembolic event (including Transient Ischemic Attack [TIA]) within the past 12 months (365 days) Uncontrolled heart failure or New York Heart Association (NYHA) function class IV Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days) Implanted with a prosthetic valve Active illness or active systemic infection or sepsis Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention [PCI]) Atrial septal closure within the past 6 weeks (42 days) Presence of a condition that precludes vascular access Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being Concurrent enrollment in an investigational study evaluating another device or drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTRELL Mapping Catheter<br>Participants diagnosed with cardiac arrhythmias who are scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures will be using multi-electrode OPTRELL mapping catheter. | Device: OPTRELL Mapping Catheter<br>* Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the management of Atrial procedure (Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation) and Ventricular procedures (Ventricular Tachycardia, Premature Ventricular Complex).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter | Number of participants with SAEs within 7 days of index procedure related to the OPTRELL catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Up to 7 days of index procedure at Day 0 | 
| Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters | Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported. | Up to 72 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With SAEs Within 7 Days of Index Procedure | Number of participants with SAEs within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Up to 7 days of index procedure at Day 0 | 
| Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter | Number of participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 7 days of index procedure at Day 0 | 
| Number of Responders for Physician Assessment for Maneuverability & Handling | Number of responders for physician assessment for maneuverability & handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability & handling. | Up to 72 days | 
| Number of Responders for Physician Assessment for Signal Collection and Quality | Number of responders for physician assessment for signal collection and quality were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality | Up to 72 days | 
| Number of Responders for Physician Assessment for Pacing | Number of responders for physician assessment for pacing (local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing. | Up to 72 days | 
| Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping | Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design in OPTRELL catheter for mapping. | Up to 72 days | 
| 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. | Up to 72 days | 
| 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. | Up to 72 days | 
| 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. | Up to 72 days | 
| Number of Responders for Physician Assessment for Arrhythmogenicity | Number of responders with physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity. | Up to 72 days | 
| Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI | Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI. | Up to 72 days | 
| 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. | Up to 72 days |