Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

Official Title
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Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Treatment with IntellaNav StablePoint Ablation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following: a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes in the patient's history within the last 6 months prior to enrollment, and any electrocardiographically documented AF episode within 12 months prior to enrollment. Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation; Subjects refractory or intolerant to at least one class I or class III antiarrhythmic medication or contraindicated to any class I or class III medications; Subjects who are willing and capable of providing informed consent; Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center; Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law. Exclusion Criteria: Subjects with New York Heart Association (NYHA) Class III or IV heart failure < 180 days prior to enrollment Left atrial diameter > 5.0 cm or left atrial volume >50 ml/m² indexed based on the most recent echocardiography+ Left ventricular ejection fraction < 35% based on the most recent echocardiogram + Continuous AF lasting longer than seven (7) days Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical) Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Subjects who have undergone any cardiac ablation or any surgery within 30 days prior to enrollment Currently implanted with a pacemaker, ICD, CRT device, or an implanted arrhythmia loop recorder Active systemic infection Unstable angina or ongoing myocardial ischemia Myocardial Infarction (MI) within 90 days prior to enrollment Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++ Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI, coronary stenting procedures) ≤ 90 days prior to enrollment. Severe valvular disease, including mechanical prosthetic mitral or tricuspid heart valves (patients with successful mitral valve repair allowed - annular ring constitutes repair); Any prior history of documented cerebral infarct, TIA or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] <180 days prior to enrollment Moderate or severe mitral stenosis (severity assessed on the most recent TTE ≤180 days prior to enrollment. Defined as pulmonary artery systolic pressure >30 mmHg) Presence of left atrial appendage closure device Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder Subjects who, in the judgment of the investigator, have a life expectancy of less than two (2) years Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion) Amiodarone use within 60 days prior to enrollment Any carotid stenting or endarterectomy Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR <45 mL/min) Known coagulopathy disorder (e.g. von Willebrand's disease, hemophilia) Any known contraindication to an AF ablation Any known contraindication for anticoagulation (e.g. patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation) Vena cava embolic protection filter devices and/or known femoral thrombus that prevents catheter insertion from the femoral approach Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication Rheumatic Heart Disease Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter Subjects unable or unwilling to complete follow-up visits and examinations for the duration of the clinical study Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility. LVEF and LA diameters obtained ≤180 days prior to enrollment will be acceptable, unless a cardiac event has occurred (e.g. MI) between the date of the exam and the enrollment date. In this case, a new echocardiogram (trans-thoracic or trans-esophageal, or intracardiac echo) must be performed to confirm eligibility prior to performing ablation. If no recent (≤180 days prior to enrollment) echocardiogram is available at the time of the enrollment, a new echocardiogram must be performed either prior to enrolling the patient into the study or post-consent to confirm patient's eligibility prior to performing the ablation. For TTE, LA anteroposterior diameter measured by M-mode from the parasternal long-axis view will be used. If both LA diameter and volume are available and at least one of them meets the exclusion criteria, the subject is considered ineligible for the study. The absence of thrombus must be confirmed by means of a trans-esophageal echocardiogram (TEE) within 48 hours prior to the procedure or Intracardiac Echography (ICE) during the procedure in subjects not adequately anticoagulated per Section 10.4.2. If a thrombus is observed, the subject no longer meets eligibility criteria and should be considered Consent Ineligible.
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 with Ablation Catheter<br>Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation | Device: Treatment with IntellaNav StablePoint Ablation Catheter<br>* Patients will be treated with an ablation catheter<br>* Other names: IntellaNav StablePoint Catheter System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Primary Safety Events at 1-Month Post-Procedure | The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure. | Up to 30 Days | 
| Freedom from Treatment Failure at 6-Months Post-Procedure | The primary effectiveness endpoint at 6 months is defined as event-free rate, which will be evaluated at a six-month interim analysis. | Up to 6 Months | 
| Rate of Primary Safety Events at 12-Months Post-Procedure | The primary safety endpoint at 12 months is defined as the safety event-free rate at 12 months post-procedure. | 12 Months | 
| Freedom from Treatment Failure at 12-Months Post-Procedure | The twelve-month effectiveness endpoint is defined as the event-free rate at twelve-month post-procedure. | 12 Months | 
| Number of Participants that achieved electrical isolation of all pulmonary veins | The primary effectiveness endpoint of acute procedural success is defined as the achievement of electrical isolation of all PVs using the IntellaNav StablePoint catheter only. | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of SAEs and AEs through 12-Months Post-Procedure | Secondary Safety Endpoint - SAE and AE Rates | 12 Months | 
| Number of patients with New or Increased Dose of AAD | Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD | 12 Months | 
| Freedom from primary effectiveness failure without a repeat procedure | Secondary Effectiveness Endpoint 2 - Single Procedure Success defined as freedom from primary effectiveness failure without a repeat procedure | 12 Months | 
| Freedom from documented symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence | Secondary Effectiveness Endpoint 3 - Symptomatic Recurrence: freedom from documented symptomatic AF/AT/AFL recurrence | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, StablePoint, Paroxysmal Atrial Fibrillation