Identification for the Treatment of Complex Arrhythmias

Study Overview
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Brief Summary
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The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.

Official Title
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Identification for the Treatment of Complex Arrhythmias (CartoFinder™ Algorithm Trial: CF163 EU)

Conditions
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Arrhythmias

Intervention / Treatment
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* Device: CartoFinder™ Device with CARTO® 3 System V5 Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Signed the Patient Informed Consent Form (ICF) Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of Persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days). Drug-resistant Atrial Fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate) Persistent AF despite prior conventional ablation. Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI). In AF at the time of the Pre-CartoFinder Map (spontaneous or induced) Able and willing to comply with all pre-, post-, and follow-up testing and requirements. Exclusion Criteria: Paroxysmal Atrial Fibrillation Continuous AF > 12 months (1-Year) (Longstanding Persistent AF) Cardioversion refractory (The inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. If a patient does not have documented evidence of being successfully cardioverted (Normal Sinus Rhythm (NSR) > 30 secs), the patient must be cardioverted prior to the ablation procedure. Failure to cardiovert based on the above criteria is considered a screen failure. A complex arrhythmia secondary to a reversible or non-cardiac cause. For example: a complex arrhythmia secondary to electrolyte imbalance or thyroid disease. Left atrial size >55 mm (echocardiography, parasternal long axis view). Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. Structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor), significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator. Enrollment in an experimental study evaluating another device or drug under investigation. Prosthetic valve Presence of intramural thrombus, tumor or other abnormality / condition that precludes vascular access, catheter introduction or manipulation. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Use of CartoFinder™ device with CARTO® 3 System V5 Navigation to treat complex arrhythmias | Device: CartoFinder™ Device with CARTO® 3 System V5 Navigation<br>* Ablation treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify rate of slowing for the overall mean atrial fibrillation rate | Identify rate of slowing for the overall mean atrial fibrillation rate that can be achieved by using CARTOFINDER™ 4D LAT Algorithm | Day 0 (procedure date) | 
| Evaluate Freedom from procedure-related primary adverse events | Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate procedural results | Proportion of subjects with focal impulses / Repetitive Activation Pattern (RAP)s and number of areas and locations of focal impulses / RAPs | Day 0 (procedure date) | 
| Evaluate procedural results | Proportion of subjects with Normal Sinus Rhythm (NSR) after CF guided ablation | Day 0 (procedure date) | 
| Evaluate procedural results | Proportion of subjects with AF organization after CF guided ablation | Day 0 (procedure date) | 
| Evaluate procedural results | Proportion of subjects with acute procedural success, i.e. subjects with spontaneous return to NSR or AF organization after CF guided ablation | Day 0 (procedure date) | 
| Evaluate freedom from documented recurrence of atrial fibrillation | Evaluate freedom from documented recurrence of atrial fibrillation at 6 and 12 months post-procedure | 6 and 12 months |