RecruitingParoxysmal AF

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Eligible age

18–80 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: Medtronic Cardiac Ablation Solutions

You may qualify if…

✓ 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 evaluations for the full length of the study.

You may not qualify if…

✕ 1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \> 7 days
✕ 2. AF that required three (3) or more distinct cardioversions in the preceding 12 months.
✕ 3. LA anteroposterior \> 5.0 cm (by MRI, CT, or TTE)
✕ 4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
✕ 5. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
✕ 6. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
✕ 7. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
✕ 8. Presence of any pulmonary vein stents