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Active Not Recruiting
NCT06858306
SPHERE Per-AF Post-Approval Study
Conditions: Persistent Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Medtronic Cardiac Ablation Solutions
Location: University of Alabama at Birmingham Hospital Birmingham Alabama
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 Criteria
Inclusion Criteria:
1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
3. Patient is ≥ 18 years of age
4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
5. Patient is willing and able to comply with study requirements and give informed consent
Exclusion Criteria:
1. Long-standing persistent AF (continuous AF sustained \>12 months)
2. Prior left atrial catheter or surgical ablation
3. Life expectancy \
Source: ClinicalTrials.gov (NCT06858306). StuddyBuddy aggregates publicly available trial information.
