Eligibility Module

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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 @ 12:43 PM
Ignite Modification Date: 2025-12-24 @ 12:43 PM
NCT ID: NCT05812261
Eligibility Criteria: Inclusion Criteria: * Age \> 18 years of age on the day of enrolment of either sex * Willing to the sign informed consent * Left atrial volume index measured \< 60 ml/m2 within last 12 months * Documented atrial fibrillation * Admitted and accepted for PVI * A left common ostium of the pulmonary veins identified by CT or MRI * Accepted to receive general anaesthesia Exclusion Criteria: * Patients aged \< 18 * Body mass index \> 35kg/m2 * Left atrial volume index ≥ 60 ml/m2 within 12 months on MRI or cardiac echo * New York Heart Association heart failure class III or IV * Myocardial infarction within three months before the procedure * Unstable angina pectoris * Percutaneous coronary interventions within three months before the procedure * Sudden cardiac death event within three months before the procedure * A life expectancy of less than one year * Presence of an atrial tachycardia other than cavotricuspid isthmus-dependent atrial flutter * History of blood clotting or bleeding abnormalities * History of a thromboembolic event within six months before the procedure * A contraindication to anticoagulant * Clinical significant infection * Unstable clinical significant medical condition * Previous left atrium ablation, except successful accessory pathway ablation * Presence of a left appendage closure device * Presence of an atrial septum occluder * Presence of a prosthetic heart valve * Occlusion of the inferior venous tract * Enrolment in another study that would interfere with this study
Sex: ALL
Minimum Age: 18 Years
Study: NCT05812261
Study Brief:
Protocol Section: NCT05812261