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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
477
Minimally invasive catheter mapping and ablation procedure
Arrhythmia Institute at Grandview
Birmingham, Alabama, United States
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
Time frame: 180 Days
Percent of Subjects Free From Primary Effectiveness Failure
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.
Time frame: 12 months
Energy Application Time
Total energy application time during the index ablation procedure
Time frame: Day 0
Treatment Time
Time from start to end of energy delivery
Time frame: Day 0
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Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Pacific Heart Institute
Santa Monica, California, United States
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Washington D.C., District of Columbia, United States
Naples Heart Institute
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Maimonides Medical Center
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
...and 13 more locations
Procedure Time
Time from start to end of venous access
Time frame: Day 0