Pulsed field ablation versus cryoballoon ablation for persistent atrial fibrillation
Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Kitasato University Academic / other |
| Locations | 1 site (Sagamihara, Kanagawa) |
| Trial ID | NCT07064616 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sagamihara, Kanagawa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.