Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.

Official Title
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A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: SpherePVI™ Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic paroxysmal atrial fibrillation (PAF) documented by: A physician's note indicating recurrent, self-terminating AF At least two electrocardiographically documented AF episodes within 12 months prior to enrollment Failure or intolerance of at least one Class I-IV anti-arrhythmic drug. Suitable candidate for catheter ablation. Age ≥ 18 and < 75 years. Able and willing to give informed consent. Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements. Exclusion Criteria: Continuous AF lasting more than 7 days. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure) Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). Any carotid stenting or endarterectomy. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure. Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure. Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function). Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days). Documented left atrial thrombus on imaging. History of blood clotting or bleeding abnormalities. Any condition contraindicating chronic anticoagulation. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure. Body mass index >40 kg/m2. Left atrial diameter >50 mm (anteroposterior). Diagnosed atrial myxoma. Left ventricular ejection fraction (EF) < 40%. Uncontrolled heart failure or NYHA Class III or IV heart failure. Rheumatic heart disease. Hypertrophic cardiomyopathy. Unstable angina. Moderate to severe mitral valve stenosis. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2 ). Primary pulmonary hypertension. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. Renal failure requiring dialysis. Acute illness, active systemic infection, or sepsis. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence. Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. Known drug or alcohol dependency. Life expectancy less than 12 months. Vulnerable subject.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: SpherePVI™ Catheter<br>Subjects treated with the SpherePVI™ Catheter | Device: SpherePVI™ Catheter<br>* Affera SpherePVI™ Multi-Ablation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects experiencing a primary safety event | The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs) occurring within 7 days of the index ablation procedure: Death Myocardial infarction Persistent phrenic nerve palsy Transient ischemic attack (TIA) Stroke/cerebrovascular accident (CVA) Thromboembolism Major vascular access complications / bleeding Heart block Gastroparesis Severe pericarditis Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE Cardiac tamponade / perforation (up to 30 days) Pulmonary vein stenosis (up to 180 days) Atrio-esophageal fistula (up to 180 days) | 6 months | 
| Percentage of subjects with acute procedure success | The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device | Index ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects experiencing a device- or procedure-related serious adverse event | The secondary safety outcome is the proportion of subjects experiencing device- or procedure-related serious adverse events (SAEs) as assessed at each follow-up visit | 12 months | 
| Product performance evaluated on a 5-point semi-quantitative scale (strongly disagree to strongly agree) | Acute product performance will be evaluated during the procedure and includes the following: SpherePVI™ Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: catheter delivery to the desired ablation sites completion of ablation procedure safe removal of catheter from the subject Electroanatomical navigation and/or mapping sufficient to aid the procedure (if used) Generation of acceptable acute ablation lesions | Index ablation procedure | 
| Percentage of subjects free from documented recurrence outside of the blanking period | Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period. Failure will be reported as both (i) recurrence of AF and (ii) recurrence of any atrial tachyarrhythmia (AF, atrial tachycardia, or atrial flutter). | 12 Months | 
| Percentage of pulmonary veins remaining isolated at remapping | Chronic efficacy may also be evaluated during an optional remapping procedure and will include the following: The number of pulmonary veins that remain isolated The number of patients with all pulmonary veins isolated | 75 days |