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

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 Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Catheter ablation using pulsed field ablation; Device: Catheter ablation using cryoballoon ablation

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hidehira Fukaya, MD, PhD; Phone Number: 2064 +81-778-8111; Email: hidehira@med.kitasato-u.ac.jp

Study Locations

• Japan
  • Kanagawa
    • Sagamihara, Kanagawa, Japan
      • Recruiting
      • Kitasato University School of Medicine
      • Contact: Hidehira Fukaya, MD, PhD.; Phone Number: 2064 +81-778-8111; Email: hidehira@med.kitasato-u.ac.jp
      • Principal Investigator: Hidehira Fukaya, MD, PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulsed-Filed Ablation (PFA) group; The PFA group includes persistent AF patients treated with PFA	Device: Catheter ablation using pulsed field ablation; 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.
Active Comparator: Cryoballoon (CBA) group; The CBA group includes persistent AF patients treated with CBA	Device: Catheter ablation using cryoballoon ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from atrial fibrillation recurrence at 12 months	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.	12 months post-procedure

Collaborators and Investigators

• Sponsor: Kitasato University
• Collaborators: Nerima Hikarigaoka Hospital; Sagamihara Kyodo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 5, 2025
• First Submitted That Met QC Criteria: July 5, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cryoballoon ablation; Pulsed-field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: C24-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No