NCT06026345
Affera Global Registry
StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)
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Record History
All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗
- Minor Enrollment closed, study ongoing
- Trial sites expanded: 12 → 20 locations
- Eligibility criteria expanded, about 5 words
- Minor Study sites: 10 to 12v6
- Minor Study sites: 1 to 10v5
- Notable Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure to Medtronic Cardiac Ablation Solutions
- Start date: Dec 6, 2023 to Dec 22, 2023
- Notable Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 1
- Notable Start date: Sep 6, 2023 to Dec 6, 2023v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Primary Objective #1 (Efficacy)
Timeframe: 12 Month Post Proceedure
Secondary (1)
Primary Objective #2 (Safety)
Arms and interventions
Treatment Arm
Patients enrolled and treated with the Affera Platform
Devices: Affera Platform
Sites
20 sites in 13 countries
France 3, Germany 3, Czechia 2, Spain 2, United Kingdom 2, Austria 1, Belgium 1, Greece 1, Ireland 1, Italy 1, Slovakia 1, Sweden 1, Switzerland 1