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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT05426759
Eligibility Criteria:
Inclusion Criteria:
* Age is between 18 and 70 years.
* Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement
* Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.
* Legally competent and willing to sign the informed consent.
* Life expectancy of at least 2 years.
Exclusion Criteria:
* Previous cardiac surgery
* Prior pericardial interventions
* Prior endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy
* Previous or existing pericarditis
* Use of amiodarone within the previous 12 months.
* Long-standing persistent atrial fibrillation
* Indication for mitral or tricuspid valve surgery
* Indication for concomitant left atrial appendage (LAA) ligation or excision
* History of previous radiation therapy on the thorax
* History of previous thoracotomy.
* Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA)
* The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs)
* Myocardial infarction within the previous 2 months
* New York Heart Association (NYHA) Class IV heart failure symptoms
* Left Ventricular Ejection Fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE)
* Left atrial diameter \> 5.0 cm, measured by transthoracic echocardiography (TTE)
* The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE)
* The presence of atrial fibrillation (AF) attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes
* Active infection or sepsis as evidenced by increased white blood cell count, elevated C-reactive protein (CRP) or temperature \> 38.5°C
* Known or documented carotid stenosis \> 80%
* Stroke or transient ischemic attack within the previous 6 months
* Known or documented epilepsy
* Pregnancy or child-bearing potential without adequate contraception
* Circumstances that prevent follow-ups
* Drug abuse
* Patients cannot be enrolled in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05426759
Study Brief:
Protocol Section:
NCT05426759