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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT04512794
Eligibility Criteria:
Inclusion Criteria:
1. Male or female ≥ 18 years of age at the time of consent
2. Clinically indicated and scheduled for a de novo catheter ablation of a complex left atrial arrhythmia including AF/AT/AFL
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, renal failure, or sepsis.
2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
3. Any DCCV within 60-days of the index procedure where sinus rhythm was not maintained for at least 60-minutes.
4. Any cardiac defibrillator (ICD) or pacemaker implanted within 8-weeks prior to the ablation procedure.
5. History of previous left atrial ablation (including surgical treatment) for AF/AT/AFL.
6. Structural heart disease or cardiac history including:
1. Left ventricular ejection fraction (LVEF) \< 35% based on a 2-d transthoracic echocardiogram (TTE) within the previous 180-days prior to enrollment.
2. Left atrial size \> 60 mm (parasternal long-axis view) based on 2-d TTE within the previous 180-days prior to enrollment.
3. Prior history of New York Heart Association (NYHA) Class IV heart failure.
4. Any evidence of NYHA Class III heart failure in the previous 3-months prior to enrollment.
5. Unstable angina or ongoing myocardial ischemia.
6. Myocardial infarction (STEMI) within the previous 180-days (sub-endocardial infarct within previous 90-days) prior to enrollment.
7. Moderate or severe valvular heart disease (stenosis or regurgitation).
8. Presence of a left atrial appendage occlusion device.
7. Body Mass Index (BMI) \> 40kg/m2
8. History of blood clotting or bleeding disease.
9. History of chronic obstructive pulmonary disease (COPD) requiring use of oxygen in the treatment regimen.
10. History of obstructive sleep apnea not currently being treated.
11. Pregnant or lactating (current or anticipated during study follow-up).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04512794
Study Brief:
Protocol Section:
NCT04512794