RecruitingNCT06858306
SPHERE Per-AF Post-Approval Study
SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
Sponsor
Medtronic Cardiac Ablation Solutions
Enrollment
200 participants
Start Date
Sep 25, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
- Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
- Patient is ≥ 18 years of age
- Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
- Patient is willing and able to comply with study requirements and give informed consent
Exclusion Criteria5
- Long-standing persistent AF (continuous AF sustained \>12 months)
- Prior left atrial catheter or surgical ablation
- Life expectancy \<36 months
- 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)
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
Interventions
DEVICESphere-9™ Catheter and Affera™ Ablation System
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06858306
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