OPTIMUM: A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OPTRELL Mapping Catheter 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
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).
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Serious Adverse Events (SAEs) within 7 days of Index Procedure Related to the OPTRELL Catheter [Up to 7 days of index procedure]
Number of Participants with SAEs within 7 days of index procedure related to the OPTRELL catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. A SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-participant hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
- Number of Participants with Pre-ablation Mapping with the OPTRELL Catheter Without Resort to Other Mapping Catheters [For 1 day on the day of procedure (anytime during the study duration of 99 days)]
Number of participants with pre-ablation mapping with the OPTRELL catheter without resort to other mapping catheters will be reported.
- Number of Participants with Clinically Indicated Mapping Performed Successfully with the OPTRELL Catheter Without Resort to Other Mapping Catheters [Up to 99 days]
Number of participants with clinically indicated mapping performed successfully with the OPTRELL catheter without resort to other mapping catheters will be reported. Pre-ablation mapping is considered complete when all of the following are accomplished, as applicable: 1) The entire chamber and areas associated with the targeted arrhythmia(s) are completely mapped using Fast Anatomical Mapping (FAM); 2) Substrate or previous lesion line associated with the arrhythmia(s) is mapped: a) Substrate Voltage mapping recommended for re-do Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PsAF) and Ventricular Tachycardia (VT) procedures; b) Local activation mapping recommended for complex Atrial Tachycardia (AT) and VT procedures; 3) Conduction channel, gap(s) and critical isthmus are identified (as applicable); 4) Mapping density at the areas of interests (example slow conduction zones) is adequate, as assessed by the investigator.
Secondary Outcome Measures
- Physician Assessment of Deployment, Maneuverability, and Signal Quality Acquired with the OPTRELL Catheter for Mapping in the Atria and Ventricles Using a Physician-completed Survey [Up to 99 days]
Physician assessment on deployment, maneuverability, and signal quality acquired with the OPTRELL Catheter for mapping in the atria and ventricles will be reported. A post-procedure survey of 11 questions, each with individual sub-questions will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.
- Number of Participants with SAEs within 7 days of Index Procedure [Up to 7 days of index procedures]
Number of Participants with SAEs within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. A SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-participant hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
- Number of Participants with Non-serious Adverse Events within 7 days of Index Procedure Associated with the Use of the OPTRELL Catheter [Up to 7 days of index procedures]
Number of Participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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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
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Signed Participant Informed Consent Form (ICF).
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Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
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Diagnosed with an arrhythmia requiring epicardial mapping
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Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
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Atrial arrhythmias: participants with a left atrial size greater than (>) 55 millimeters (mm)
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Left Ventricular Ejection Fraction (LVEF) less than or equal to (<=) 25 percent (%) for Ventricular Tachycardia (VT) participants
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LVEF <= 40% for participants with atrial arrhythmia
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Documented intracardiac thrombus as detected on imaging
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Contraindication to anticoagulation (that is heparin, warfarin, dabigatran)
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History of blood clotting or bleeding abnormalities (example hypercoagulable state)
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Myocardial infarction within the past 2 months (60 days)
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Documented thromboembolic event (including Transient Ischemic Attack [TIA]) within the past 12 months (365 days)
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Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
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Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
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Implanted with a prosthetic valve
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Active illness or active systemic infection or sepsis
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Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
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Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
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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)
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Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention [PCI])
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Atrial septal closure within the past 6 weeks (42 days)
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Presence of a condition that precludes vascular access
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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
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Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
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Concurrent enrollment in an investigational study evaluating another device or drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Antwerpen | Antwerpen | Belgium | 2650 | |
| 2 | Virga Jessa Ziekenhuis | Hasselt | Belgium | 3500 | |
| 3 | Vilnius University Hospital Santaros Clinics | Vilnius | Lithuania | 8661 |
Sponsors and Collaborators
- Biosense Webster, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- BWI_2019_02
- CIV-BE-21-04-036524
- BWI_2019_02