Pulsed field ablation versus cryoballoon ablation for persistent atrial fibrillation
Official title: Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
Run by Kitasato University · NCT07064616 · Data updated 2026-11-12
This study will test whether pulsed field ablation or cryoballoon ablation better restores and keeps a normal heart rhythm in adults with persistent atrial fibrillation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Kitasato University Academic / other |
| Locations | 1 site (Sagamihara, Kanagawa) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT07064616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–85 with persistent atrial fibrillation lasting less than one year or requiring cardioversion who are eligible for catheter ablation under Japanese guidelines and can give informed consent.
✕Probably not a fit
People with paroxysmal AF, long-standing persistent AF longer than one year, or those who are not candidates for catheter ablation are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with persistent atrial fibrillation who are eligible for catheter ablation will undergo ablation using either pulsed field ablation or cryoballoon ablation and will be followed for rhythm outcomes and safety. The trial enrolls patients aged 18–85 whose persistent AF has lasted less than one year or required cardioversion, following current Japanese guidelines. Key measurements include recurrence of atrial fibrillation, procedure-related complications, and symptom improvement over scheduled follow-up visits. The study is conducted at Kitasato University School of Medicine with collaborating regional hospitals in Kanagawa, Japan.
Why it matters
Potential benefit: If successful, this could identify a safer or more effective ablation method to reduce AF recurrence and symptoms for people with persistent AF.
How similar studies have gone: Cryoballoon ablation is an established technique and early studies of pulsed field ablation show promising safety and effectiveness, but direct comparisons in persistent AF remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Kitasato University School of Medicine
Sagamihara, Kanagawa, Japan Recruiting
Study contacts
- Study coordinator: Hidehira Fukaya, MD, PhD
- Email: hidehira@med.kitasato-u.ac.jp
- Phone: +81-778-8111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Qidong Yixin Granules to prevent atrial fibrillation returning after ablation
This trial tests whether taking Qidong Yixin Granules after catheter ablation can lower the chance of atrial fibrillation coming back within a year in adults with persistent AF.
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FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation
This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.
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PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.