Atrial FibrillationBRAVE PFONCT07123506
Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure
A study testing Beta-blocker treatment group and Non-treatment group in people with Atrial Fibrillation and Atrial Flutter, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular
- What is being tested?
- Beta-blocker treatment group and Non-treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2025to 3 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul
About this study
"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.
Read more
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
- Being tested
- Beta-blocker treatment group, Non-treatment group
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-blocker treatment groupDrug
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 groupDrug
After PFO closure, the non-treatment group will not receive a beta-blocker.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Beta-blocker treatment group |
| Non-treatment group | Experimental | After PFO closure, the non-treatment group will not receive a beta-blocker. Receives: Drug: Non-treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after Patent Foramen Ovale closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study startSep 2025 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion3 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123506
- Sponsor's protocol ID
- 4-2025-0005
- Acronym
- BRAVE PFO
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure
- ClinicalTrials.gov ID
- NCT07123506
- Acronym / sponsor ID
- BRAVE PFO / 4-2025-0005
- Conditions
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Heart Septal Defects, Atrial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 3 May 2029 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-blocker treatment group | Experimental | Drug: Beta-blocker treatment groupAfter 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 | Experimental | Drug: Non-treatment groupAfter PFO closure, the non-treatment group will not receive a beta-blocker. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-blocker treatment groupAfter 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 groupAfter PFO closure, the non-treatment group will not receive a beta-blocker. | Drug | Non-treatment group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-blocker treatment group and Non-treatment group in people with Atrial Fibrillation and Atrial Flutter, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Arrhythmias Within 30 Days After PFO Closure (time frame: Within 30 days after Patent Foramen Ovale closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.