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

NCT ID: NCT07064616

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed-Filed Ablation (PFA) group

The PFA group includes persistent AF patients treated with PFA

Group Type: ACTIVE_COMPARATOR

Catheter ablation using pulsed field ablation

Intervention Type: 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.

Cryoballoon (CBA) group

The CBA group includes persistent AF patients treated with CBA

Group Type: ACTIVE_COMPARATOR

Catheter ablation using cryoballoon ablation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nerima Hikarigaoka Hospital

UNKNOWN

Sponsor Role: collaborator

Sagamihara Kyodo Hospital

UNKNOWN

Sponsor Role: collaborator

Kitasato University

OTHER

Sponsor Role: lead

Responsible Party

Hidehira Fukaya

Junior Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kitasato University School of Medicine

Sagamihara, Kanagawa, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Hidehira Fukaya, MD, PhD

Role: CONTACT

hidehira@med.kitasato-u.ac.jp

+81-778-8111 ext. 2064

Facility Contacts

Hidehira Fukaya, MD, PhD.

Role: primary

hidehira@med.kitasato-u.ac.jp

+81-778-8111 ext. 2064

Other Identifiers

C24-157

Identifier Type: -

Identifier Source: org_study_id