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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT05931835
Eligibility Criteria:
Key Inclusion Criteria:
* Subject is 18 to 80 years of age at the time of consent
* Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
* Subject is able to understand and willing to provide written informed consent
Key Exclusion Criteria:
* Any of the following within 6 months prior to enrolment:
* Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
* Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
* Myocardial infarction
* Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
* Dilated or hypertropic cardiomyopathy
* Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
* Any of the following cardiac conditions:
* New York Heart Association (NYHA) class IV
* Left ventricular ejection fraction (LVEF) \< 30%
* Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder)
* Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
* Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
* Body mass index (BMI) \> 40 kg/m2
* Body weight \< 50kg
* Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure)
* Life expectancy less than 12 months
* Subjects who are currently enrolled in another study
* Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05931835
Study Brief:
Protocol Section:
NCT05931835