Atrial FibrillationPEACE-AFNCT06952023
PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF
A study testing Modified Maze ablation with PFA and PVI only with PFA in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by The First Affiliated Hospital of Dalian Medical University at 3 sites in China.
Trial summary
In radiofrequency (RF) ablation of persistent atrial fibrillation (PeAF), the additional linear ablation beyond pulmonary vein isolation (PVI) does not yield an reduce atrial arrhythmias recurrences.The goal of this clinical trial is to evaluate the efficiency of pulsed filed (PF) energy-based bi-atrial modified Maze… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Modified Maze ablation with PFA and PVI only with PFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2025to Oct 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with symptomatic PeAF at 18-75 years old who are eligible for the PFA procedure, and have any the following documentation, within 180 days of randomization of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days，OR iii. physician note of persistent continuous AF for > 7 days
- The duration of AF lasting ≥ 1 year
Who cannot join
- PaAF or PeAF with duration < 1 year
- has received catheter ablation procedure for AF or atrial septal defect repair before enrollment
- left atrial diameter ≥55 mm or thrombosis in the left atrium
- eGFR<30mL/min/1.73m2
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack)
- acute or severe systemic infection
Show all 10Show fewer
- refused to participate in this trial; or those who have participated in other clinical drug trials within 3 months prior to enrollment
- congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio > 1.5 or partial activated prothrombin time prolonged by ≥ 10 seconds, or plasma prothrombin time prolonged by ≥ 3 seconds, or fibrinogen ≤ 1.5 g/L), or active bleeding
- pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
- life expectancy < 12 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiaomeng Yin, Ph.D, +86 18098875778, dr.yinxm@163.com
Xiaomeng Yin, Ph.D
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210029
Fengxiang Zhang, +86 13952037301, 13952037301@139.com
Fengxiang Zhang
The Affiliated Hospital Of Medical School Of Ningbo University
Ningbo, Zhejiang, 315211
About this study
Official title: Pulsed Field-Based Bi-atrial Maze-like Catheter Ablation Versus Pulmonary Vein Isolation in Persistent Atrial Fibrillation: A Multi-center Randomized Controlled Trial
In radiofrequency (RF) ablation of persistent atrial fibrillation (PeAF), the additional linear ablation beyond pulmonary vein isolation (PVI) does not yield an reduce atrial arrhythmias recurrences.The goal of this clinical trial is to evaluate the efficiency of pulsed filed (PF) energy-based bi-atrial modified Maze ablation vs PF energy-based PVI of PeAF.
The main questions it aims to answer are:
Read more
Does PF energy effectively perform linear ablation in the left atrium? Does PFA-based bi-atrial modified Maze ablation significantly improve the success rate of PeAF ablation compared with PFA-based PVI?
Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI only) in a 1:1 ratio. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
Read the detailed description
Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI only) in a 1:1 ratio. In the study group, patients will receive PF energy based PVI, BOX ablation, LA anterior wall linear ablation from the right superior pulmonary vein to the mitral annulus (under sinus rhythm), MI ablation, linear ablation of the RA posterior wall (up to the superior vena cava and down towards the inferior vena cava according to the potential), and CTI ablation. The patients in the control group will received PVI only with PF energy. If the patients do not restore to sinus rhythm, they will receive electrical cardioversion.
All patients received guideline-directed standardized drug therapy, including anti-arrhythmic medications, postoperatively. Discontinuation of all anti-arrhythmic drugs after the blanking period. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
- Being tested
- Modified Maze ablation with PFA, PVI only with PFA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Maze ablation with PFAProcedure or surgery
Modified Maze ablation with PFA
PVI only with PFAProcedure or surgery
PVI only with PFA
| Study group | Role | What they receive |
|---|---|---|
| PF-based modified Maze ablation | Experimental | patients will receive PF energy based PVI, BOX ablation, LA anterior wall linear ablation from the right superior pulmonary vein to the mitral annulus (under sinus rhythm), MI ablation, linear ablation of the RA posterior wall (up to the superior vena cava and down towards the inferior vena cava according to the potential), and CTI ablation. Receives: Procedure: Modified Maze ablation with PFA |
| RF-based PVI only | Active comparator | PVI only with PF energy Receives: Procedure: PVI only with PFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial tachycardia during blanking period to Month 12
freedom of occurrence ≥ 30 sec of Atrial Fibrillation (AF), Atrial Flutter (AFL), atrial Tachycardia (AT); or any electrical cardioversion or re-ablation for AF, AFL, or AT; or any Class I or III AAD use
Measured: during blanking period to Month 12
Secondary outcomes (3)
Acute Success - Isolation rate of attempted pulmonary veins and left atrial linear ablation
Isolation rate of attempted pulmonary veins and left atrial linear ablation
Measured: intraprocedure
device or procedure-related Composite Adverse Events
device or procedure-related Composite Adverse Events including Heart block, Myocardial infarction, Peripheral or organ thromboembolism, Stroke/ Cerebrovascular accident/Transient ischemic attack (TIA),Unresolved phrenic nerve palsy / paresis,Vascular access complications
Measured: day 0 to 12 months
procedure time
procedure time
Measured: intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952023
- Sponsor's protocol ID
- maze001
- Acronym
- PEACE-AF
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun Y, Dai S, Xiao X, Wang Z, Yu X, Ma C, Zhang R, Gao L, Xia Y, Yin X. Tailored bi-atrial linear ablation guided by electrophysiological mapping for persistent atrial fibrillation. BMC Cardiovasc Disord. 2024 Nov 20;24(1):658. doi: 10.1186/s12872-024-04332-w.
PubMed 39567904
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field-Based Bi-atrial Maze-like Catheter Ablation Versus Pulmonary Vein Isolation in Persistent Atrial Fibrillation: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06952023
- Acronym / sponsor ID
- PEACE-AF / maze001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Apr 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.
In radiofrequency (RF) ablation of persistent atrial fibrillation (PeAF), the additional linear ablation beyond pulmonary vein isolation (PVI) does not yield an reduce atrial arrhythmias recurrences.The goal of this clinical trial is to evaluate the efficiency of pulsed filed (PF) energy-based bi-atrial modified Maze ablation vs PF energy-based PVI of PeAF.
The main questions it aims to answer are:
Does PF energy effectively perform linear ablation in the left atrium? Does PFA-based bi-atrial modified Maze ablation significantly improve the success rate of PeAF ablation compared with PFA-based PVI?
Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI only) in a 1:1 ratio. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
Detailed description
Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI only) in a 1:1 ratio. In the study group, patients will receive PF energy based PVI, BOX ablation, LA anterior wall linear ablation from the right superior pulmonary vein to the mitral annulus (under sinus rhythm), MI ablation, linear ablation of the RA posterior wall (up to the superior vena cava and down towards the inferior vena cava according to the potential), and CTI ablation. The patients in the control group will received PVI only with PF energy. If the patients do not restore to sinus rhythm, they will receive electrical cardioversion.
All patients received guideline-directed standardized drug therapy, including anti-arrhythmic medications, postoperatively. Discontinuation of all anti-arrhythmic drugs after the blanking period. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-based modified Maze ablation | Experimental | Procedure: Modified Maze ablation with PFApatients will receive PF energy based PVI, BOX ablation, LA anterior wall linear ablation from the right superior pulmonary vein to the mitral annulus (under sinus rhythm), MI ablation, linear ablation of the RA posterior wall (up to the superior vena cava and down towards the inferior vena cava according to the potential), and CTI ablation. |
| RF-based PVI only | Active comparator | Procedure: PVI only with PFAPVI only with PF energy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with symptomatic PeAF at 18-75 years old who are eligible for the PFA procedure, and have any the following documentation, within 180 days of randomization of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days，OR iii. physician note of persistent continuous AF for > 7 days
- The duration of AF lasting ≥ 1 year
Key exclusion criteria (10 listed)
- PaAF or PeAF with duration < 1 year
- has received catheter ablation procedure for AF or atrial septal defect repair before enrollment
- left atrial diameter ≥55 mm or thrombosis in the left atrium
- eGFR<30mL/min/1.73m2
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack)
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 |
|---|---|---|
| Modified Maze ablation with PFAModified Maze ablation with PFA | Procedure or surgery | PF-based modified Maze ablation |
| PVI only with PFAPVI only with PFA | Procedure or surgery | RF-based PVI only |
Primary outcome
Freedom from atrial tachycardia during blanking period to Month 12
Time frame: during blanking period to Month 12
freedom of occurrence ≥ 30 sec of Atrial Fibrillation (AF), Atrial Flutter (AFL), atrial Tachycardia (AT); or any electrical cardioversion or re-ablation for AF, AFL, or AT; or any Class I or III AAD use
3 secondary outcomes
Acute Success - Isolation rate of attempted pulmonary veins and left atrial linear ablation
Time frame: intraprocedure
device or procedure-related Composite Adverse Events
Time frame: day 0 to 12 months
procedure time
Time frame: intraprocedure
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 30 Apr 2025.
- Background: PubMed 39567904Sun Y, Dai S, Xiao X, Wang Z, Yu X, Ma C, Zhang R, Gao L, Xia Y, Yin X. Tailored bi-atrial linear ablation guided by electrophysiological mapping for persistent atrial fibrillation. BMC Cardiovasc Disord. 2024 Nov 20;24(1):658. doi: 10.1186/s12872-024-04332-w.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Maze ablation with PFA and PVI only with PFA in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by The First Affiliated Hospital of Dalian Medical University at 3 sites in China.
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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 Xiaomeng Yin, Ph.D (+86 18098875778, dr.yinxm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial tachycardia during blanking period to Month 12 (time frame: during blanking period to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952023, which also lists 1 linked publication.
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 30 Apr 2025.