Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation

Last updated: August 24, 2025
Sponsor: Kitasato University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

Catheter ablation using cryoballoon ablation

Catheter ablation using pulsed field ablation

Clinical Study ID

NCT07064616
C24-157
  • Ages 18-85
  • All Genders

Study 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

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

Exclusion Criteria:

  • Paroxysmal or long-standing persistent AF (duration >1 year)

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Catheter ablation using cryoballoon ablation
Phase:
Study Start date:
June 25, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Kitasato University School of Medicine

    Sagamihara, Kanagawa
    Japan

    Site Not Available

  • Kitasato University School of Medicine

    Sagamihara 11611609, Kanagawa 1860291
    Japan

    Active - Recruiting

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