Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)
Medtronic Cardiac Ablation Solutions
Summary
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following: 1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and 2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment 2. Adults who are ≥18 and ≤80 years of age on the day of enrollment. 3. Willing and able to comply with all baseline and follow-up evalu…
Interventions
- DeviceSphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Locations (12)
- Arrhythmia Research GroupJonesboro, Arkansas
- Northwestern UniversityChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Southcoast Health SystemFall River, Massachusetts
- The Valley HospitalParamus, New Jersey
- Icahn School of Medicine at Mount SinaiNew York, New York