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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT04061603
Eligibility Criteria:
INCLUSION CRITERIA
IC1 Male or female between the ages of 18 and 80 years
IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained \> 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF \> 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment.
IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired)
IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
IC5 Willingness and ability to give an informed consent
EXCLUSION CRITERIA
EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis
EC 2 Any duration of continuous AF lasting longer than 12-months
EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
EC 5 Structural heart disease as described below:
1. Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE
2. Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening
3. NYHA Class III or IV heart failure documented within the previous 12-months
4. An implanted pacemaker or ICD
5. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
7. Interatrial baffle, closure device, patch, or PFO occluder
8. Presence of a left atrial appendage occlusion device
9. Presence of any pulmonary vein stenting devices
10. Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure
11. Unstable angina or ongoing myocardial ischemia
12. Myocardial infarction within the previous six (6) months prior to procedure
13. Moderate or severe mitral insufficiency or stenosis based on most recent TTE
14. Atrial myxoma
15. Significant congential anomaly
EC 6 BMI \> 40
* BMI \>35 and no prior sponsor approval into the study
EC 7 Any previous history of cryoglobulinemia
EC 8 History of blood clotting or bleeding disease
EC 9 History of severe COPD requiring steroid use in the previous 12-months
EC 10 History of severe sleep apnea (AHI \> 30) not currently treated with a CPAP machine or other mechanical device
EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)
EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis
EC 13 Pregnant or lactating (current or anticipated during study follow-up)
EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
EC 15 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, COVID-19 related concerns)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04061603
Study Brief:
Protocol Section:
NCT04061603