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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05514860
Eligibility Criteria:
Inclusion Criteria:
* Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
* Age of 18 years or older on the date of consent
* Candidate for ablation based on AF that is symptomatic
* Informed Consent
Exclusion Criteria:
* Regular (daily) use of a class 1 or 3 antiarrhythmic drug (pill-in-the-pocket AAD use is permitted) at sufficient therapeutic doses according to guidelines (flecainide \>50 mg BID, sotalol \>80 mg BID, propafenone \>150 mg BID Previous left atrial (LA) ablation or LA surgery
* AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
* Active Intracardiac Thrombus
* Pre-existing pulmonary vein stenosis or PV stent
* Pre-existing hemidiaphragmatic paralysis
* Contraindication to anticoagulation or radiocontrast materials
* Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
* Cardiac valve prosthesis
* Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
* Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
* Cardiac surgery during the three-month interval preceding the consent date
* Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
* NYHA class III or IV congestive heart failure
* Left ventricular ejection fraction (LVEF) less than 35%
* Hypertrophic cardiomyopathy (septal or posterior wall thickness \>1.5 cm)
* Significant Chronic Kidney Disease (CKD - eGFR \<30 µMol/L)
* Uncontrolled hyperthyroidism
* Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
* Pregnancy
* Life expectancy less than one (1) year
* Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
* Unwilling or unable to comply fully with study procedures and follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05514860
Study Brief:
Protocol Section:
NCT05514860