Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure

Launched by YONSEI UNIVERSITY · Aug 7, 2025

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ClinConnect Summary

This clinical trial is looking at whether taking a type of medicine called beta-blockers can help prevent certain heart rhythm problems, like atrial fibrillation, atrial flutter, and atrial tachycardia, after a procedure to close a small hole in the heart called a patent foramen ovale (PFO). The procedure uses a device called the Cocoon PFO Occluder. The researchers want to see if patients who take beta-blockers after the procedure have fewer episodes of these irregular heartbeats within 30 days compared to those who don’t take the medicine. They will also check how safe and effective the closure device is and gather information about how patients do in real life after the procedure.

People eligible for the study are adults aged 19 or older who are scheduled to have the PFO closure using the Cocoon device and who agree to participate. However, people with a history of irregular heart rhythms, certain lung problems, severe heart issues, or those who cannot start or stop beta-blockers safely won’t be able to join. If accepted, participants will be randomly assigned to either take beta-blockers (specifically low doses of bisoprolol or nebivolol) or not take them. Doctors will monitor their heart rate and blood pressure and may adjust the medicine dose as needed. The study will carefully track any changes or side effects to help determine if beta-blockers are helpful and safe after PFO closure.

Gender

ALL

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