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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07405359
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years at their pre-procedure visit
* Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs\>7 days apart or ≥3 cardioversions
* Indicated and interested in ICM implant for monitoring post ablation
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Exclusion Criteria:
* Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
* Stroke or transient ischemic attack within the previous six months
* Gastrointestinal bleeding within the previous three months
* Implanted pacemaker or defibrillator
* Longstanding persistent AF (\> 3 years)
* LA volume \>80ml/m2
* Atrial septal occlusion device
* Current left atrial thrombus
* Left atrial appendage occlusion or closure device \< 6 mos or with leak or prior DRT
* Mitral or Tricuspid valve clip or mechanical replacement or clip
* Hypertrophic cardiomyopathy
* Contraindication to femoral vascular access
* Congenital heart disease with residual anatomic abnormality
* Contraindication to, or unwillingness to use, systemic anticoagulation
* Pregnancy
* Left ventricular ejection fraction \<30%
* Baseline creatinine \>2.0 mg/dL
* Predicted life expectancy less than one year
* Refusal to receive ICM implant or allergy to ICM
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07405359
Study Brief:
Protocol Section:
NCT07405359