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

NCT07064616 | Recruiting

• 1 other identifier: C24-157
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Keywords

Pulsed-field ablation; Cryoballoon ablation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pulsed-Filed Ablation (PFA) group

ACTIVE COMPARATOR

The PFA group includes persistent AF patients treated with PFA

Device: Catheter ablation using pulsed field ablation

Cryoballoon (CBA) group

ACTIVE COMPARATOR

The CBA group includes persistent AF patients treated with CBA

Device: Catheter ablation using cryoballoon ablation

Interventions

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.

Pulsed-Filed Ablation (PFA) group

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.

Cryoballoon (CBA) group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Paroxysmal or long-standing persistent AF (duration \>1 year)

Sponsors & Collaborators

• Kitasato University: lead
• Nerima Hikarigaoka Hospital: collaborator
• Sagamihara Kyodo Hospital: collaborator

Study Sites (1)

Kitasato University School of Medicine

Sagamihara, Kanagawa, Japan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hidehira Fukaya, MD, PhD

CONTACT

+81-778-8111; hidehira@med.kitasato-u.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Associate Professor

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 15, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-06

Locations

JP (1)