Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System
Objective
The purpose of the study is to provide data demonstrating the safety and effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for treating paroxysmal atrial Fibrillation (PAF).
Eligibility
Key Inclusion Criteria:
- 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:
- A physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
- At least 1 electrocardiographically documented episode within 12 months prior to enrollment
- Adults who are ≥18 and ≤80 years of age on the day of enrollment.
- Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Key Exclusion Criteria:
- Continuous AF lasting more than 7 days
- Prior Catheter or Surgical Ablation
- AF that required three or more distinct cardioversions in the preceding 12 months
- LA anteroposterior >5.0cm (by MRI, CT, or TTE)
- Patient who is not on OAC therapy for at least 3 weeks prior to the ablation procedure
- Presence of any PPM, BIV PPM, ILR, ICM, or any type of implantable cardiac defibrillator
- Prior valvular (surgical or percutaneous) procedure or Moderate to severe aortic or mitral valve disease
- EF <40%
NCT ID
NCT07308847
