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Clinical Trials/NCT07064616
NCT07064616RecruitingNot Applicable

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

Kitasato University2 sites in 1 country300 target enrollmentStarted: June 25, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
2
Primary Endpoint
Freedom from atrial fibrillation recurrence at 12 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Pulsed-Filed Ablation (PFA) group

Active Comparator

The PFA group includes persistent AF patients treated with PFA

Intervention: Catheter ablation using pulsed field ablation (Device)

Cryoballoon (CBA) group

Active Comparator

The CBA group includes persistent AF patients treated with CBA

Intervention: Catheter ablation using cryoballoon ablation (Device)

Outcomes

Primary Outcomes

Freedom from atrial fibrillation recurrence at 12 months

Time Frame: 12 months post-procedure

Proportion of patients without documented atrial fibrillation lasting 30 seconds or longer after a 3-month blanking period following the ablation procedure, assessed by ECG or Holter monitoring.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hidehira Fukaya

Junior Associate Professor

Kitasato University

Study Sites (2)

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