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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05113056
Eligibility Criteria:
Inclusion Criteria:
1. Male or female between the ages of 18 to 80 years at time of consent
2. Clinically indicated and scheduled for a de novo catheter ablation of AF
3. Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
Exclusion Criteria:
1. In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
2. Continuous episodes of AF duration lasting longer than 12-months
3. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
4. Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
5. Structural heart disease or cardiac history as described below:
1. Left ventricular ejection fraction (LVEF) \< 35%
2. Left atrial size \> 60 mm
3. Evidence of heart failure (NYHA Class III or IV)
4. Unstable angina or ongoing myocardial ischemia
5. Recent myocardial infarction
6. Severe uncontrolled systemic hypertension
7. Moderate or severe valvular heart disease (stenosis or regurgitation).
8. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
l. Presence of a left atrial appendage occlusion device. j. Previous PV stenting or evidence of PV stenosis.
6. Body Mass Index (BMI) \> 42 kg/m2
7. History of blood clotting or bleeding disease.
8. ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
9. History of obstructive sleep apnea not currently being treated.
10. Pregnant or lactating (current or anticipated during study follow-up).
11. Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05113056
Study Brief:
Protocol Section:
NCT05113056