NCT07123506Not yet recruiting
Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure
Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
"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."
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07123506
What you commit to
- Study type: Interventional
- Planned participants: 350
- From Sept 2025 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients for whom initiating or discontinuing beta-blocker therapy is deemed impossible by the investigator
- Patients currently participating in another investigational drug or device study
Other illness
- 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 hypersensitivity or contraindications to any proposed drug therapy or device component
Lab values
- History of heart failure, severe valvular disease, or left ventricular dysfunction (ejection fraction \<50%)
Other
- Patients with high-degree atrioventricular (AV) block
- Patients who, as assessed by the investigator, cannot be followed up for one year after enrollment
- Patients with an expected life expectancy of less than one year
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.