Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure

NCT07123506 | Not Yet Recruiting DMC

• 1 other identifier: 4-2025-0005
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Atrial Fibrillation; Atrial Flutter; Tachycardia, Supraventricular; Heart Septal Defects, Atrial

Outcome Measures

Primary Outcomes (1)

• Atrial Arrhythmias Within 30 Days After PFO 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.

  Within 30 days after Patent Foramen Ovale closure

Study Arms (2)

Beta-blocker treatment group

EXPERIMENTAL

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.

Drug: Beta-blocker treatment group

Non-treatment group

EXPERIMENTAL

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

Drug: Non-treatment group

Interventions

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.

Beta-blocker treatment group

Non-treatment group DRUG

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

Non-treatment group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Tachycardia, Supraventricular; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): May 3, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)