NCT07064616 Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
| NCT ID | NCT07064616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kitasato University |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-06-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical study is being conducted to compare two different treatment methods for persistent atrial fibrillation (AF), a common heart rhythm disorder. Atrial fibrillation occurs when the upper chambers of the heart (the atria) beat rapidly and irregularly. This can lead to symptoms like palpitations, shortness of breath, or fatigue, and it increases the risk of stroke or heart failure. Persistent atrial fibrillation means that the irregular heart rhythm continues and does not stop on its own. Treatment often includes a procedure called catheter ablation, where special instruments are used to create small scars in the heart to block the abnormal electrical signals causing the arrhythmia. Currently, two main types of catheter ablation are used in Japan: Cryoballoon Ablation: A technique that uses extreme cold to create scars and isolate the pulmonary veins, which are often the source of the irregular signals. Pulsed Field Ablation (PFA): A newer technique that uses very short bursts of electrical energy to target the heart tissue, with the aim of reducing damage to surrounding structures. While pulsed field ablation has been introduced in Japan recently and seems to be safe, there is limited data about how well it works compared to cryoballoon ablation, especially in patients with persistent atrial fibrillation. This study aims to find out whether pulsed field ablation is as effective and safe as cryoballoon ablation for treating persistent AF.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 85 years * Diagnosed with PeAF (lasting less than one year or requiring cardioversion) * Eligible for catheter ablation according to current Japanese guidelines * Provided written informed consent Exclusion Criteria: * Paroxysmal or long-standing persistent AF (duration \>1 year)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07064616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07064616 currently recruiting?
Yes, NCT07064616 is actively recruiting participants. Contact the research team at hidehira@med.kitasato-u.ac.jp for enrollment information.
Where is the NCT07064616 trial being conducted?
This trial is being conducted at Sagamihara, Japan.
Who is sponsoring the NCT07064616 clinical trial?
NCT07064616 is sponsored by Kitasato University. The trial plans to enroll 300 participants.
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