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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05617456
Eligibility Criteria:
Inclusion Criteria:
* Patients with an indication to an ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
* Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
* Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
* Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
* Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
* Life expectancy ≤ 12 months per physician judgment.
* Unrecovered/unresolved Adverse Events from any previous invasive procedure;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
* Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
* AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05617456
Study Brief:
Protocol Section:
NCT05617456