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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT06056557
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older.
* Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
* Previous surgical or catheter ablation for atrial fibrillation is allowed
* Planned for a catheter ablation procedure
* Able and willing to provide written consent and comply with all testing and follow-up requirements
* Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm
Exclusion Criteria:
* Documented "active" left atrial thrombus
* Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
* Previous PCI/MI within the past 1 month
* Active systemic infection or sepsis
* Uncontrolled heart failure - New York Heart Association (NYHA) function class IV.
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
* Life expectancy or other disease processes likely to limit survival to less than 12 months.
* Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06056557
Study Brief:
Protocol Section:
NCT06056557