Beta-blockers for Prevention of Arrhythmia Following PFO Closure

Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010345

Enrollment

350

Registered

2025-03-28

Start date

2025-03-31

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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 strati

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
The rate of at least one episode of atrial fibrillation lasting more than 30 seconds is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial flutter lasting more than 30 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial tachycardia lasting more than 30 seconds is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial fibrillation lasting more than 360 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial flutter lasting more than 360 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial tachycardia lasting more than 360 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial fibrillation lasting more than 30 seconds is monitored using an AT Patch 3-day Holter electrocardiogram.;The rate of at least one episode of atrial flutter lasting more than 30 seconds is monitored using an AT Patch 3-day Holter electrocardiogram.; The rate of at least one episode of atrial tachycardia lasting more than 30 seconds is monitored using an AT Patch 3-day Holter electrocardiogram.;The rate of at least one episode of atrial fibrillation la	—

Measure

Time frame

The rate of at least one episode of atrial fibrillation lasting more than 30 seconds is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial flutter lasting more than 30 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial tachycardia lasting more than 30 seconds is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial fibrillation lasting more than 360 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial flutter lasting more than 360 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial tachycardia lasting more than 360 seconds within 30 days is monitored using an AT Patch 14-day Holter electrocardiogram, followed by additional clinical evaluation and electrocardiogram confirmation 15 days later.;The rate of at least one episode of atrial fibrillation lasting more than 30 seconds is monitored using an AT Patch 3-day Holter electrocardiogram.;The rate of at least one episode of atrial flutter lasting more than 30 seconds is monitored using an AT Patch 3-day Holter electrocardiogram.; The rate of at least one episode of atrial tachycardia lasting more than 30 seconds is monitored using an AT Patch 3-day Holter electrocardiogram.;The rate of at least one episode of atrial fibrillation la

—

Countries

Korea, Republic of

Contacts

Public ContactJung-Sun kim

Yonsei University Health System, Severance Hospital

kjs1218@yuhs.ac+82-2-2228-8457

Outcome results