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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT07123506
Eligibility Criteria:
Inclusion Criteria:
1. Age 19 years or older
2. Patients scheduled to undergo Patent Foramen Ovale closure using the Cocoon Patent Foramen Ovale Occluder
3. Individuals who have provided informed consent for study participation
Exclusion Criteria:
1. History of paroxysmal, persistent, or permanent atrial arrhythmia
2. Atrial arrhythmia confirmed by a 14-day Holter ECG using the AT Patch before PFO closure
3. Patients with uncontrolled asthma or chronic obstructive pulmonary disease (COPD)
4. Patients with high-degree atrioventricular (AV) block
5. History of heart failure, severe valvular disease, or left ventricular dysfunction (ejection fraction \<50%)
6. Patients for whom initiating or discontinuing beta-blocker therapy is deemed impossible by the investigator
7. Patients who, as assessed by the investigator, cannot be followed up for one year after enrollment
8. Patients with hypersensitivity or contraindications to any proposed drug therapy or device component
9. Patients with an expected life expectancy of less than one year
10. Patients currently participating in another investigational drug or device study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07123506
Study Brief:
Protocol Section:
NCT07123506