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:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT06488820
Eligibility Criteria:
Inclusion Criteria:
* Age: \>≥18 years
* Symptomatic Paroxysmal or Persistent AF patients of ≤ 1 year
* First ablation or redo procedure to treat AF
* Willing to provide written informed consent
* Able and willing to comply with all testing and requirements
Exclusion Criteria:
* Long-standing persistent AF Page 17 of 70
* Any condition contraindicating chronic anticoagulation
* Prosthetic mechanical valves
* Recent MI (in \<3 months)
* Active systemic infection
* Pregnant or lactating women
* Current enrollment in an investigational study evaluating another device or drug.
* Documented left atrial (LA) thrombus by imaging within 48 hours before procedure (computed tomography (CT), transesophageal echocardiogram (TEE), or intracardiac echocardiogram (ICE) at the beginning of the procedure).
* Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Life expectancy less than 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06488820
Study Brief:
Protocol Section:
NCT06488820