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 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT05461859
Eligibility Criteria:
Inclusion Criteria:
* Paroxysmal atrial fibrillation
* Deceleration capacity \>7ms
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 ≥ 5.5 cm
* Significant valvular disease
* Prosthetic valve
* Heart failure New York Heart Association (NYHA) class III/IV
* Previous AF ablation
* History of a persistent oval opening/atrial septal defect closure
* History of left atrial appendage closure
* Atrial myxoma
* Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
* Symptomatic hypotension
* History of pericarditis
* Congenital heart disease
* History of coagulation disorders
* Contraindications to oral anticoagulation
* Contraindications to computed tomography or magnetic resonance imaging
* 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
* Lack of informed consent to participate in the trial
* Participation in another trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05461859
Study Brief:
Protocol Section:
NCT05461859