UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057896 |
|---|---|
| Receipt number | R000066150 |
| Scientific Title | PulsE field Ablation versus Cryoballoon ablation in patients with pErsistent atrial fibrillation: PEACE trial |
| Date of disclosure of the study information | 2025/05/18 |
| Last modified on | 2025/08/24 15:22:30 |
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Basic information
Public title
PulsE field Ablation versus Cryoballoon ablation in patients with pErsistent atrial fibrillation: PEACE trial
Acronym
PEACE trial
Scientific Title
PulsE field Ablation versus Cryoballoon ablation in patients with pErsistent atrial fibrillation: PEACE trial
Scientific Title:Acronym
PEACE trial
Region
| Japan |
Condition
Condition
Persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with persistent atrial fibrillation scheduled for catheter ablation will be randomized into a pulsed field ablation group and a cryoballoon group to compare the recurrence of atrial arrhythmias one year after the procedure (efficacy) and the incidence of perioperative complications within 30 days (safety).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Efficacy Endpoints
Efficacy will be assessed using the following composite endpoints:
Recurrence of atrial tachyarrhythmia: Recurrence is defined as any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or more within one year after a 90-day post-procedure blanking period, or the need for repeat ablation. Assessment will be conducted using 24-hour Holter monitoring at 6 and 12 months. Additionally, arrhythmias detected on 12-lead ECGs during emergency visits for palpitations will also be included.
Acute procedural failure: If the treatment cannot be completed using only the cryoballoon catheter or the pulsed field ablation catheter and requires additional devices (e.g., radiofrequency ablation catheters), it will be considered a procedural failure.
2) Safety Endpoints
The incidence of procedure-related complications occurring during the procedure or within 30 days postoperatively will be assessed. The perioperative period is defined as within 30 days after the procedure, during which the following complications will be evaluated: air embolism during the procedure, cardiac tamponade, cerebral infarction (including TIA), systemic embolism, vascular complications, phrenic nerve palsy, esophageal complications, and gastric peristalsis disorders.
Secondary Endpoints
1) Differences in left atrial diameter reduction (preoperative, 6 months, and 12 months postoperatively)
2) Changes in blood biomarkers such as BNP and NT-proBNP (preoperative, 6 months, and 12 months postoperatively)
3) Relationship between atrial arrhythmia recurrence during the blanking period and recurrence in the late phase
4) Evaluation of subjective symptoms on the day after the procedure using the Numeric Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 to 10 used to self-assess pain and discomfort, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cryoballoon group
Interventions/Control_2
PulseSelect group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with persistent atrial fibrillation scheduled to undergo catheter ablation treatment.
Persistent atrial fibrillation is defined, according to relevant guidelines, as atrial fibrillation that persists for up to one year, or cases requiring antiarrhythmic drugs or electrical cardioversion.
Indications for catheter ablation will follow the Guidelines for Non-Pharmacotherapy of Arrhythmias (2018 revision) and the Focused Update of the Arrhythmia Treatment Guidelines (2024) issued by the Japanese Circulation Society and the Japanese Heart Rhythm Society.
Patients aged between 18 and 85 years at the time of consent.
Patients capable of providing written informed consent.
Key exclusion criteria
Patients with paroxysmal atrial fibrillation.
Patients with long-standing persistent atrial fibrillation lasting more than one year.
Patients who have previously undergone catheter ablation or surgical ablation.
Patients with a left atrial diameter greater than 55 mm.
Patients for whom cryoballoon ablation or pulsed field ablation is not suitable:
--Patients judged unable to receive contrast media due to conditions such as chronic kidney disease, bronchial asthma, or contrast agent allergy (contrast media is required for cryoballoon ablation).
Any other patients deemed unsuitable by the attending physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidehira |
| Middle name | |
| Last name | Fukaya |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
252-0734
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
hidehira@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehira |
| Middle name | |
| Last name | Fukaya |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
hidehira@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine / Hospital Ethics Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
042-778-8111
rinri_b@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066150
