Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07064616

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kitasato University School of Medicine

Sagamihara, Kanagawa, Japan

Location status: Recruiting

Location contact

Hidehira Fukaya, MD, PhD.

CONTACT

[email protected]

+81-778-8111 ext. 2064

Hidehira Fukaya, MD, PhD.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Catheter ablation using pulsed field ablation

Device

PulseSelect™ Pulsed Field Ablation System:

This intervention uses the PulseSelect™ system to perform pulsed field ablation (PFA) for pulmonary vein isolation in patients with persistent atrial fibrillation. PFA delivers short, high-voltage electrical pulses that selectively affect myocardial cells while minimizing damage to surrounding tissues such as the esophagus or phrenic nerve. This technique is designed to reduce procedural complications and improve safety compared to traditional thermal ablation methods.

Catheter ablation using cryoballoon ablation

Device

Cryoballoon Ablation:

This intervention uses a cryoballoon catheter to perform pulmonary vein isolation by freezing tissue around the pulmonary veins. The balloon delivers extreme cold temperatures to create transmural lesions that block abnormal electrical signals responsible for atrial fibrillation. Cryoballoon ablation is widely used and considered effective for atrial fibrillation treatment but may carry risks related to collateral tissue injury.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hidehira Fukaya, MD, PhD

CONTACT

[email protected]

+81-778-8111 ext. 2064

Sponsors and collaborators

Lead sponsor

Kitasato University

Other

Collaborators

  • Nerima Hikarigaoka Hospital
  • Sagamihara Kyodo Hospital

Registry information

Acronym: PEACE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 15, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.