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 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT03775512
Eligibility Criteria:
Key Inclusion Criteria:
* Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.
* Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD.
* Age 18 years or older.
Key Exclusion Criteria:
* Previous surgical or catheter ablation for atrial fibrillation.
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days.
* Valve repair or replacement or presence of a prosthetic valve.
* CABG surgery within the past 6 months (180 days).
* Any carotid stenting or endarterectomy within the past 6 months.
* Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
* Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
* Documented LA size \> 50 mm.
* Documented LVEF \< 40%.
* Contraindication to anticoagulation (e.g., heparin).
* MI/PCI within the past 2 months.
* Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
* Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
* Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
* Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03775512
Study Brief:
Protocol Section:
NCT03775512