Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

Study Overview
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Brief Summary
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This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).

Official Title
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Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Mapping and Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF. Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD). Suitable candidate for catheter ablation. Adults aged 18 - 80 years. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Willing and able to provide informed consent. Exclusion Criteria: Continuous AF lasting for 12 months or longer. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause. Previous left atrial ablation or surgical procedure (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 the 90 days prior to the initial procedure. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure. Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function). Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure. 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 >55 mm (anterioposterior). Diagnosed atrial myxoma. Left ventricular ejection fraction (EF) < 35%. 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. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention. Acute illness, active systemic infection, or sepsis. Contraindication to both computed tomography and magnetic resonance angiography. 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 study 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 study of a drug, device, or biologic during the duration of the study not 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 (such as a prisoner or handicapped or mentally disabled person).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sphere-9 Catheter<br>Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System | Device: Mapping and Ablation<br>* Minimally invasive catheter mapping and ablation procedure<br>|
| Active Comparator: THERMOCOOL SMARTTOUCH SF<br>THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System | Device: Mapping and Ablation<br>* Minimally invasive catheter mapping and ablation procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with a primary adverse event | The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: Death Myocardial infarction Phrenic nerve paralysis Transient ischemic attack (TIA) Stroke/cerebrovascular accident (CVA) Thromboembolism Major vascular access complications / bleeding Heart block Gastroparesis Severe pericarditis Hospitalization due to cardiovascular or pulmonary AE Within 30 days: • Cardiac tamponade / perforation Within 90 days: • Atrio-esophageal fistula Within 180 days: • Pulmonary vein stenosis | 180 Days | 
| Percent of subjects free from primary effectiveness failure | The primary effectiveness endpoint is freedom from documented recurrence of atrial tachyarrhythmias excluding the 90-day blanking period. The following are also considered primary effectiveness endpoint failures: Acute procedural failure Non-study catheter failure Repeat ablation/surgery failure AAD failure Cardioversion failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy application time | Total energy application time during the index ablation procedure | Day 0 | 
| Treatment time | Time from start to end of energy delivery | Day 0 | 
| Procedure time | Time from start to end of venous access | Day 0 |