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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT03867266
Eligibility Criteria:
Inclusion criteria:
* paroxysmal, persistent and /or long standing atrial flutter even in the presence of structural heart disease
* Informed consent form
* Age equal or above 18 years
* Skilled and willing to comply with all tests and follow up requirements
* Patients that ,in the context of ablation for fibrillation atrial, should also undergo to typical flutter ablation: in this case the data collected will be those related to typical flutter ablation.
Exclusion Criteria:
* Previous ablation for atrial flutter
* Atrial flutter secondary to electrolyte imbalance, thyroid disease or to a reversible or non-cardiac cause
* severe anemia,
* sepsis in progress
* Bypass procedure with coronary arterial artery in the last three months
* Pending cardiac transplantation or other cardiac surgery
* Pregnant or breastfeeding women
* Acute disease or active systemic infection or sepsis
* Documented left atrial thrombus
* Unstable angina
* Uncontrolled heart failure
* Life expectancy of less than 12 months
* Registration in any other study evaluating another device or medication
* Presence of intramural thrombi, tumor or other anomalies that preclude the introduction of the catheter into the vein system
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03867266
Study Brief:
Protocol Section:
NCT03867266