Persistent Atrial FibrillationPEACENCT07064616
Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
A study testing Catheter ablation using pulsed field ablation and Catheter ablation using cryoballoon ablation in people with Persistent Atrial Fibrillation, run by Kitasato University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation using pulsed field ablation and Catheter ablation using cryoballoon ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- 25 Jun 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Paroxysmal or long-standing persistent AF (duration >1 year)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Kitasato University School of Medicine
Sagamihara, Kanagawa
Hidehira Fukaya, MD, PhD., +81-778-8111 ext. 2064, hidehira@med.kitasato-u.ac.jp
Hidehira Fukaya, MD, PhD.
About this study
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.
Read more
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
- Being tested
- Catheter ablation using pulsed field ablation, Catheter ablation using cryoballoon ablation
- Keywords
- Pulsed-field ablation, Cryoballoon ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using pulsed field ablationDevice
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 ablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed-Filed Ablation (PFA) group | Active comparator | The PFA group includes persistent AF patients treated with PFA Receives: Device: Catheter ablation using pulsed field ablation |
| Cryoballoon (CBA) group | Active comparator | The CBA group includes persistent AF patients treated with CBA Receives: Device: Catheter ablation using cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start25 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kitasato University
- Sponsor type
- University, hospital or other
- Collaborators
- Nerima Hikarigaoka Hospital, Sagamihara Kyodo Hospital
- Responsible party
- Principal investigator, Hidehira Fukaya, Kitasato University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064616
- Sponsor's protocol ID
- C24-157
- Acronym
- PEACE
- Status last verified
- Jun 2025
- First submitted
- 5 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07064616
- Acronym / sponsor ID
- PEACE / C24-157
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Pulsed-field ablation, Cryoballoon ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kitasato UniversityUniversity, hospital or other
- Collaborators
- Nerima Hikarigaoka Hospital, Sagamihara Kyodo Hospital
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed-Filed Ablation (PFA) group | Active comparator | Device: Catheter ablation using pulsed field ablationThe PFA group includes persistent AF patients treated with PFA |
| Cryoballoon (CBA) group | Active comparator | Device: Catheter ablation using cryoballoon ablationThe CBA group includes persistent AF patients treated with CBA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Paroxysmal or long-standing persistent AF (duration >1 year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablation using pulsed field ablationPulseSelect™ 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. | Device | Pulsed-Filed Ablation (PFA) group |
| Catheter ablation using cryoballoon ablationCryoballoon 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. | Device | Cryoballoon (CBA) group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using pulsed field ablation and Catheter ablation using cryoballoon ablation in people with Persistent Atrial Fibrillation, run by Kitasato University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hidehira Fukaya, MD, PhD (+81-778-8111 ext. 2064, hidehira@med.kitasato-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation recurrence at 12 months (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.