Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure

"The primary objective of the study is to evaluate whether the incidence of symptomatic or asymptomatic atrial fibrillation, atrial flutter, and atrial tachycardia within 30 days after percutaneous closure of idiopathic patent foramen ovale is reduced in the beta-blocker treatment group compared to the non-treatment group.

The secondary objective is to assess the safety and performance of the Cocoon Patent Foramen Ovale Occluder and collect real-world data on patient outcomes.

Patients will be randomly assigned in a 1:1 ratio to either the beta-blocker treatment group or the non-treatment group. Randomization will be performed using a 1:1 allocation ratio with stratification based on (1) PFO device size and (2) sex, employing a block randomization method (mixed block sizes of 4 or 6). This process will be conducted independently through an interactive web response system.

The beta-blockers used in this study are extended-release beta-blockers, specifically bisoprolol or nebivolol. The choice between bisoprolol and nebivolol will be determined at the discretion of the investigators, with the initial dose set at the minimum dose for each drug (1.25 mg once daily). During the study period, adjustments to the beta-blocker dose, including maintenance or modification, will be made based on the investigators' clinical judgment, taking into account the patient's heart rate, blood pressure, and medication adherence. All reasons for dose adjustments will be documented in detail."

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Supraventricular

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 19 years or older
Patients scheduled to undergo Patent Foramen Ovale closure using the Cocoon Patent Foramen Ovale Occluder
Individuals who have provided informed consent for study participation

Exclusion criteria

History of paroxysmal, persistent, or permanent atrial arrhythmia
Atrial arrhythmia confirmed by a 14-day Holter ECG using the AT Patch before PFO closure
Patients with uncontrolled asthma or chronic obstructive pulmonary disease (COPD)
Patients with high-degree atrioventricular (AV) block
History of heart failure, severe valvular disease, or left ventricular dysfunction (ejection fraction <50%)
Patients for whom initiating or discontinuing beta-blocker therapy is deemed impossible by the investigator
Patients who, as assessed by the investigator, cannot be followed up for one year after enrollment
Patients with hypersensitivity or contraindications to any proposed drug therapy or device component
Patients with an expected life expectancy of less than one year
Patients currently participating in another investigational drug or device study

Treatment and study plan

Beta-blocker treatment group

Drug

After PFO closure, the beta-blocker treatment group will receive an extended-release beta-blocker, either bisoprolol or nebivolol, at a dose of 1.25 mg QD for 30 days.

Non-treatment group

Drug

After PFO closure, the non-treatment group will not receive a beta-blocker.

Primary outcomes

Atrial Arrhythmias Within 30 Days After PFO Closure

Time frame: Within 30 days after Patent Foramen Ovale closure

The occurrence of at least one episode of symptomatic or asymptomatic atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer within 30 days after PFO closure. Monitoring will be conducted using a 14-day Holter ECG with the AT Patch during the initial 14 days, followed by an additional clinical assessment and ECG evaluation on day 15.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: BRAVE PFO

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2029
First posted: Aug 14, 2025
Registry last updated: Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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