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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT07175727
Eligibility Criteria:
Inclusion Criteria:
* Recurrent, symptomatic paroxysmal atrial fibrillation
* Age \> 18 years
* Patient consen
Exclusion Criteria:
* Refusal of the patient
* Inability to provide informed consent
* Life expectancy \< 2 years
* Pregnancy and breastfeeding (due to radiation exposure)
* History of left atrial ablation
* Known macro-reentry or focal atrial tachycardia
* Significant mitral valve stenosis
* History of heart valve replacement or reconstruction
* NYHA class III and IV
* Left ventricular ejection fraction \< 35%
* Left atrial enlargement \> 55 mm on echocardiography
* Intracardiac thrombus prior to the procedure
* Severe pulmonary disease with abnormal blood gases or requiring oxygen therapy
* Renal insufficiency (GFR \< 30 mL/min) due to contrast medium use
* Stroke or TIA within the last 6 months
* Symptomatic carotid stenosis
* Active malignancy within the previous 24 months
* Untreated or uncontrolled thyroid disease
* Active bleeding or chronic bleeding tendency not amenable to curative treatment
* Body mass index \> 35 kg/m²
* Contraindication to CT examination (e.g., contrast medium allergy or severe claustrophobia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07175727
Study Brief:
Protocol Section:
NCT07175727