Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 477
- Locations
- 23
- Primary Endpoint
- Percent of Subjects With a Primary Adverse Event
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Subjects will be blinded to treatment assignment
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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).
Arms & Interventions
Sphere-9 Catheter
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Intervention: Mapping and Ablation (Device)
THERMOCOOL SMARTTOUCH SF
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Intervention: Mapping and Ablation (Device)
Outcomes
Primary Outcomes
Percent of Subjects With a Primary Adverse Event
Time Frame: 180 Days
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
Percent of Subjects Free From Primary Effectiveness Failure
Time Frame: 12 months
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures: * Inability to isolate all targeted pulmonary veins during the index procedure. * Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure. * Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure. * Documented AF/AT/AFL recurrence after the 90-day blanking period. * Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period. * DC cardioversion for AF/AT/AFL after the 90-day blanking period.
Secondary Outcomes
- Energy Application Time(Day 0)
- Treatment Time(Day 0)
- Procedure Time(Day 0)