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:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT06578104
Eligibility Criteria:
Inclusion Criteria
* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
* Patient is ≥ 18 years of age
* Planned pulmonary vein isolation procedure with the commercially available PulseSelectâ„¢ PFA System
* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Exclusion Criteria
* Long-standing persistent AF (continuous AF sustained \>12 months)
* Prior left atrial catheter or surgical ablation
* Patient with 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 not approved by the global study manager
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06578104
Study Brief:
Protocol Section:
NCT06578104