Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT06858306
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 \<36 months
4. 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)
5. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06858306
Study Brief:
Protocol Section:
NCT06858306