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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT06058468
Eligibility Criteria:
Inclusion Criteria:
* Paroxysmal atrial fibrillation documented in ECG or Holter monitoring
* Deceleration capacity \>7.5ms
* Life expectancy more than 1 year
* Age ≥18 years
Exclusion Criteria:
* Permanent AF lasting more than one year or persistent AF lasting more than 7 days
* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
* Anteroposterior dimension of the left atrium in the echocardiography ≥43mm
* Clinically significant arrhythmias other than AF
* Significant valvular disease
* Valve prosthesis
* Heart failure III or IV Class in New York Heart Association Classification
* Previous ablation of atrial fibrillation or atrial flutter
* History of a patent foramen ovale/atrial septal defect closure
* History of left atrial appendage closure
* Atrial myxoma
* Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
* History of pericarditis
* Congenital heart disease
* History of bleeding or coagulation disorders
* Contraindications to oral anticoagulation
* Contraindications to computed tomography or magnetic resonance imaging
* Pregnancy or breast-feeding
* BMI\>31
* History of transplantation
* Severe lung disease
* Chronic renal failure defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/m2
* Cancer
* Significant infection
* Life expectancy less than one year
* Mental disorders
* Lack of informed consent to participate in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06058468
Study Brief:
Protocol Section:
NCT06058468