Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (SPHERE Per-AF)

  • End date
    Nov 19, 2023
  • participants needed
  • sponsor
    Affera, Inc.
Updated on 19 October 2022
radiofrequency ablation
catheter ablation
antiarrhythmic drug
persistent atrial fibrillation


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).

Condition Atrial Fibrillation
Treatment Mapping and ablation
Clinical Study IdentifierNCT05120193
SponsorAffera, Inc.
Last Modified on19 October 2022


Yes No Not Sure

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)
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