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

Kitasato University

Status: Enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Device: Catheter ablation using pulsed field ablation; Device: Catheter ablation using cryoballoon ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07064616

C24-157

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Pulsed-Filed Ablation (PFA) group

Active Comparator group

Description:

The PFA group includes persistent AF patients treated with PFA

Treatment:

Device: Catheter ablation using pulsed field ablation

Cryoballoon (CBA) group

Active Comparator group

Description:

The CBA group includes persistent AF patients treated with CBA

Treatment:

Device: Catheter ablation using cryoballoon ablation