Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07064616

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

Led by Kitasato University · Updated on 2025-08-26

300

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

Sponsors

K

Kitasato University

Lead Sponsor

N

Nerima Hikarigaoka Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Diagnosed with persistent atrial fibrillation lasting less than one year or requiring cardioversion
  • Eligible for catheter ablation according to current Japanese guidelines
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Paroxysmal or long-standing persistent atrial fibrillation lasting more than one year

AI-Screening

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Trial Site Locations

Total: 1 location

1

Kitasato University School of Medicine

Sagamihara, Kanagawa, Japan

Actively Recruiting

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Research Team

H

Hidehira Fukaya, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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