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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03811795
Eligibility Criteria:
Inclusion Criteria:
* Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per recent HRS guidelines and standard practice;
* Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling institution more than 3 month or more prior to the anticipated repeat ablation;
* Age ≥ 18 years.
Exclusion Criteria:
* Individuals with recurrent AF who previously underwent RF-based PVI;
* Individuals with known contraindications to ablation including permanent atrial fibrillation or intolerance of anticoagulation;
* Individuals unable or not willing to complete follow-up visits and examination for the duration of the study;
* Individuals without access to smartphone or tablet compatible with the monitoring system;
* Prior valve surgery or surgical AF ablation;
* Individuals with mental or physical limitations precluding informed consent;
* Individuals currently enrolled in another investigational study or registry;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03811795
Study Brief:
Protocol Section:
NCT03811795