Non-paroxysmal Atrial FibrillationPEAK-AFNCT07541989
Pulsed-Field Ablation With/Without Electrogram Mapping
A study testing PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates and PFA-based PVI+PWI alone in people with Non-paroxysmal Atrial Fibrillation, run by Xu Liu at 10 sites in 2 countries.
Trial summary
Pulsed field ablation (PFA) has demonstrated favorable safety and efficacy in atrial fibrillation ablation, particularly for pulmonary vein isolation (PVI). However, the optimal PFA-based ablation strategy for non-paroxysmal atrial fibrillation remains uncertain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-paroxysmal Atrial Fibrillation
- What is being tested?
- PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates and PFA-based PVI+PWI alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 Sep 2024to 1 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:a. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agentb. ECG-documented episode of persistent AF lasting longer than 7 days c. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF2. Patients who are ≥ 18 years and <80 years 3. Patient participation requirements:a. Is willing and capable of providing Informed Consent to undergo study proceduresb. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Who cannot join
- 1. AF that is:a. Paroxysmal (longest AF episode < 7days)b. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)3. Any of the following cardiac conditions:a. Clinically significant arrhythmias other than AF, AFL or ATb. NYHA Class IV CHFc. Atrial or ventricular septal defect closured. Atrial myxomae. History of congenital heart disease with any residual anatomic or conduction abnormality4. Any of the following within 3 months of enrollment:a. Myocardial infarctionb. Unstable anginac. Percutaneous coronary interventiond. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)e. Heart failure hospitalizationf. Stroke or TIAg. Clinically significant bleedingh. Pericarditis or pericardial effusioni. Left atrial thrombus 5. History of blood clotting or bleeding abnormalities.6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Sensitivity to contrast media not controlled by premedication8. Women of childbearing potential who are pregnant, lactating or not using birth control9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited toa. Body mass index (BMI) > 40 transplantb. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspneac. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant d. Active malignancy or history of treated cancer within 24 months of enrollmente. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid refluxf. Clinically significant infectiong. Predicted life expectancy less than one year10. Current or anticipated enrollment in any other clinical study
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
China9 sites
Changshu Hospital of Traditional Chinese Medicine
Changshu, Jiangsu, 215516
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250001
Jinan City People's Hospital
Jinan, Shandong, 271100
Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital
Shanghai, 200030
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai
Shanghai, 200127
Wenling Hospital of Traditional Chinese Medicine
Wenling, Zhejiang, 317500
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Yuhuan Second People's Hospital
Yuhuan, Zhejiang, 317600
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Pulsed-Field Ablation With/Without Electrogram Mapping of Key Substrates for Non-paroxysmal Atrial Fibrillation: A Prospective Multicenter Randomized Study (PEAK-AF Study)
Pulsed field ablation (PFA) has demonstrated favorable safety and efficacy in atrial fibrillation ablation, particularly for pulmonary vein isolation (PVI). However, the optimal PFA-based ablation strategy for non-paroxysmal atrial fibrillation remains uncertain. In addition to anatomical lesion sets such as PVI and posterior wall isolation (PWI), Electrogram Mapping of Key Substrates may allow identification of residual arrhythmogenic areas that contribute to the maintenance of atrial fibrillation. In the investigators' previously completed single-center cohort study, adjunctive ablation targeting key substrates identified by electrogram mapping on top of PVI+PWI was feasible and associated with improved rhythm outcomes.
This prospective multicenter randomized controlled study is designed to compare PFA-based PVI+PWI alone versus PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates in patients with non-paroxysmal atrial fibrillation, in order to evaluate the efficacy and safety of this strategy in a broader and more rigorous clinical setting.
Read the detailed description
Pulsed field ablation (PFA) has emerged as a promising energy source for atrial fibrillation ablation because of its myocardial selectivity and favorable safety profile. Previous studies have demonstrated high procedural success and encouraging clinical outcomes for PFA-based pulmonary vein isolation (PVI), particularly in patients with paroxysmal atrial fibrillation. However, in patients with non-paroxysmal atrial fibrillation, the underlying arrhythmogenic substrate is often more complex and extends beyond the pulmonary veins, and the optimal lesion set for PFA-based ablation in this population remains to be established.
Posterior wall isolation (PWI) is commonly added to PVI in an effort to improve substrate modification in non-paroxysmal atrial fibrillation. Nevertheless, recurrence after PVI+PWI remains common, suggesting that additional mechanisms outside conventional anatomical targets may play an important role in arrhythmia maintenance. Electrogram Mapping of Key Substrates provides a strategy to identify localized abnormal electrophysiological regions that may represent critical drivers or perpetuators of atrial fibrillation and may therefore serve as adjunctive ablation targets beyond standard anatomical lesion sets.
In the investigators' previous studies of catheter ablation for persistent atrial fibrillation, substrate modification guided by electrogram characteristics showed promising efficacy. More specifically, in the investigators' completed single-center cohort study of PFA for non-paroxysmal atrial fibrillation, adjunctive ablation based on Electrogram Mapping of Key Substrates in addition to PVI+PWI was shown to be feasible and was associated with favorable rhythm control outcomes. These findings support the hypothesis that a strategy incorporating electrogram-defined key substrate identification may provide incremental benefit over PVI+PWI alone.
However, whether adjunctive ablation guided by Electrogram Mapping of Key Substrates improves clinical outcomes in a reproducible manner has not yet been validated in a prospective multicenter randomized controlled trial. Given the potential influence of operator experience and center-level variability on substrate-based ablation, a multicenter randomized design is necessary to provide more robust evidence regarding the efficacy, safety, and generalizability of this strategy.
Therefore, the present study is designed as a prospective multicenter randomized controlled trial to compare two PFA-based ablation strategies in patients with non-paroxysmal atrial fibrillation:
- PVI+PWI alone; and
- PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates.
The primary objective of this study is to determine whether the addition of ablation targeting key substrates identified by electrogram mapping improves rhythm outcomes compared with PVI+PWI alone. The study will also assess procedural characteristics and safety outcomes to further define the role of Electrogram Mapping of Key Substrates in optimizing PFA-based ablation strategies for non-paroxysmal atrial fibrillation.
- Conditions
- Non-paroxysmal Atrial Fibrillation
- Being tested
- PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates, PFA-based PVI+PWI alone
- Keywords
- non-paroxysmal atrial fibrillation, persistent atrial fibrillation, pulsed field ablation, catheter ablation, electrogram mapping, key substrate ablation, eletrogram-guided 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.
PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key SubstratesProcedure or surgery
In the experimental arm, electrogram mapping will be performed before pulmonary vein isolation (PVI) and posterior wall isolation (PWI) to identify key atrial substrates for adjunctive ablation. Mapping may be conducted using machine learning-assisted electrogram mapping, operator-guided electrogram mapping, or a combination of both, based on the same predefined criteria for target identification. Electrogram analysis will then be performed to identify target regions with the following characteristics: 1)Spatial-temporal dispersion activation; 2)Short cycle length activity; 3)Focal activity. After completion of electrogram mapping and target identification, all participants in the experimental arm will undergo standard PFA-based PVI and PWI. Adjunctive pulsed-field ablation will subsequently be delivered to the electrogram-defined key substrates identified during the pre-ablation mapping phase.
PFA-based PVI+PWI aloneProcedure or surgery
Ablation will be performed using a pulsed-field ablation system. Participants in this arm will undergo standard pulmonary vein isolation and posterior wall isolation only, without additional substrate ablation guided by electrogram mapping.
| Study group | Role | What they receive |
|---|---|---|
| EGM | Experimental | PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates: Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), followed by adjunctive ablation targeting key atrial substrates identified by predefined electrogram mapping criteria. Receives: Procedure: PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates |
| PWI | Active comparator | Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI) without adjunctive ablation guided by electrogram mapping of key substrates. Receives: Procedure: PFA-based PVI+PWI alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from any AF/AT
The feasibility primary endpoint was defined as freedom from any AF/AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 3 months, 6 months, 12 months and 36 months respectively after the procedure.
Measured: freedom from any AF/AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.
composite of major safety events
The safety endpoint is a composite of major safety events including cardiac tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack (TIA), diaphragmatic paralysis, block, pericarditis, hemolysis, myocardial infarction, PV stenosis, atrioesophageal fistula, and death. The endpoint includes events occurring within 30 days of the index or reassessment procedures.
Measured: adverse events occurring within 30 days of the index or reassessment procedures.
Secondary outcomes (2)
AF recurrence
freedom from any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment at 3 months, 6 months, 12 months and 36 months respectively
Measured: freedom from any AF at 3 months, 6 months, 12 months and 36 months respectively after the procedure
AT recurrence
any documented AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment at 3 months, 6 months, 12 months and 36 months respectively.
Measured: freedom from any AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Sep 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-paroxysmal 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
- Xu Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital of Shanghai Jiao Tong University
- Responsible party
- Sponsor-investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541989
- Sponsor's protocol ID
- PEAK-AF Study
- Acronym
- PEAK-AF
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) from this study will not be shared publicly due to concerns regarding patient confidentiality and the sensitive nature of medical data. Given the potential risks of identifying participants from detailed clinical information, the data will remain confidential and will not be made available for public sharing. Additionally, the study involves proprietary methodologies and ongoing analyses that are part of the intellectual property of the institution. As such, sharing the IPD at this stage could compromise the integrity of the study's findings and its future applications.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed-Field Ablation With/Without Electrogram Mapping of Key Substrates for Non-paroxysmal Atrial Fibrillation: A Prospective Multicenter Randomized Study (PEAK-AF Study)
- ClinicalTrials.gov ID
- NCT07541989
- Acronym / sponsor ID
- PEAK-AF / PEAK-AF Study
- Conditions
- Non-paroxysmal Atrial Fibrillation
- Keywords
- non-paroxysmal atrial fibrillation, persistent atrial fibrillation, pulsed field ablation, catheter ablation, electrogram mapping, key substrate ablation, eletrogram-guided ablation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xu LiuUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital of Shanghai Jiao Tong University
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 21 Apr 2026 (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.
Pulsed field ablation (PFA) has demonstrated favorable safety and efficacy in atrial fibrillation ablation, particularly for pulmonary vein isolation (PVI). However, the optimal PFA-based ablation strategy for non-paroxysmal atrial fibrillation remains uncertain. In addition to anatomical lesion sets such as PVI and posterior wall isolation (PWI), Electrogram Mapping of Key Substrates may allow identification of residual arrhythmogenic areas that contribute to the maintenance of atrial fibrillation. In the investigators' previously completed single-center cohort study, adjunctive ablation targeting key substrates identified by electrogram mapping on top of PVI+PWI was feasible and associated with improved rhythm outcomes.
This prospective multicenter randomized controlled study is designed to compare PFA-based PVI+PWI alone versus PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates in patients with non-paroxysmal atrial fibrillation, in order to evaluate the efficacy and safety of this strategy in a broader and more rigorous clinical setting.
Detailed description
Pulsed field ablation (PFA) has emerged as a promising energy source for atrial fibrillation ablation because of its myocardial selectivity and favorable safety profile. Previous studies have demonstrated high procedural success and encouraging clinical outcomes for PFA-based pulmonary vein isolation (PVI), particularly in patients with paroxysmal atrial fibrillation. However, in patients with non-paroxysmal atrial fibrillation, the underlying arrhythmogenic substrate is often more complex and extends beyond the pulmonary veins, and the optimal lesion set for PFA-based ablation in this population remains to be established.
Posterior wall isolation (PWI) is commonly added to PVI in an effort to improve substrate modification in non-paroxysmal atrial fibrillation. Nevertheless, recurrence after PVI+PWI remains common, suggesting that additional mechanisms outside conventional anatomical targets may play an important role in arrhythmia maintenance. Electrogram Mapping of Key Substrates provides a strategy to identify localized abnormal electrophysiological regions that may represent critical drivers or perpetuators of atrial fibrillation and may therefore serve as adjunctive ablation targets beyond standard anatomical lesion sets.
In the investigators' previous studies of catheter ablation for persistent atrial fibrillation, substrate modification guided by electrogram characteristics showed promising efficacy. More specifically, in the investigators' completed single-center cohort study of PFA for non-paroxysmal atrial fibrillation, adjunctive ablation based on Electrogram Mapping of Key Substrates in addition to PVI+PWI was shown to be feasible and was associated with favorable rhythm control outcomes. These findings support the hypothesis that a strategy incorporating electrogram-defined key substrate identification may provide incremental benefit over PVI+PWI alone.
However, whether adjunctive ablation guided by Electrogram Mapping of Key Substrates improves clinical outcomes in a reproducible manner has not yet been validated in a prospective multicenter randomized controlled trial. Given the potential influence of operator experience and center-level variability on substrate-based ablation, a multicenter randomized design is necessary to provide more robust evidence regarding the efficacy, safety, and generalizability of this strategy.
Therefore, the present study is designed as a prospective multicenter randomized controlled trial to compare two PFA-based ablation strategies in patients with non-paroxysmal atrial fibrillation:
- PVI+PWI alone; and
- PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates.
The primary objective of this study is to determine whether the addition of ablation targeting key substrates identified by electrogram mapping improves rhythm outcomes compared with PVI+PWI alone. The study will also assess procedural characteristics and safety outcomes to further define the role of Electrogram Mapping of Key Substrates in optimizing PFA-based ablation strategies for non-paroxysmal atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGM | Experimental | Procedure: PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key SubstratesPFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates: Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), followed by adjunctive ablation targeting key atrial substrates identified by predefined electrogram mapping criteria. |
| PWI | Active comparator | Procedure: PFA-based PVI+PWI aloneParticipants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI) without adjunctive ablation guided by electrogram mapping of key substrates. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:a. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agentb. ECG-documented episode of persistent AF lasting longer than 7 days c. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF2. Patients who are ≥ 18 years and <80 years 3. Patient participation requirements:a. Is willing and capable of providing Informed Consent to undergo study proceduresb. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Key exclusion criteria (1 listed)
- 1. AF that is:a. Paroxysmal (longest AF episode < 7days)b. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)3. Any of the following cardiac conditions:a. Clinically significant arrhythmias other than AF, AFL or ATb. NYHA Class IV CHFc. Atrial or ventricular septal defect closured. Atrial myxomae. History of congenital heart disease with any residual anatomic or conduction abnormality4. Any of the following within 3 months of enrollment:a. Myocardial infarctionb. Unstable anginac. Percutaneous coronary interventiond. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)e. Heart failure hospitalizationf. Stroke or TIAg. Clinically significant bleedingh. Pericarditis or pericardial effusioni. Left atrial thrombus 5. History of blood clotting or bleeding abnormalities.6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Sensitivity to contrast media not controlled by premedication8. Women of childbearing potential who are pregnant, lactating or not using birth control9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited toa. Body mass index (BMI) > 40 transplantb. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspneac. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant d. Active malignancy or history of treated cancer within 24 months of enrollmente. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid refluxf. Clinically significant infectiong. Predicted life expectancy less than one year10. Current or anticipated enrollment in any other clinical study
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 |
|---|---|---|
| PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key SubstratesIn the experimental arm, electrogram mapping will be performed before pulmonary vein isolation (PVI) and posterior wall isolation (PWI) to identify key atrial substrates for adjunctive ablation. Mapping may be conducted using machine learning-assisted electrogram mapping, operator-guided electrogram mapping, or a combination of both, based on the same predefined criteria for target identification. Electrogram analysis will then be performed to identify target regions with the following characteristics: 1)Spatial-temporal dispersion activation; 2)Short cycle length activity; 3)Focal activity. After completion of electrogram mapping and target identification, all participants in the experimental arm will undergo standard PFA-based PVI and PWI. Adjunctive pulsed-field ablation will subsequently be delivered to the electrogram-defined key substrates identified during the pre-ablation mapping phase. | Procedure or surgery | EGM |
| PFA-based PVI+PWI aloneAblation will be performed using a pulsed-field ablation system. Participants in this arm will undergo standard pulmonary vein isolation and posterior wall isolation only, without additional substrate ablation guided by electrogram mapping. | Procedure or surgery | PWI |
Primary outcome
freedom from any AF/AT
Time frame: freedom from any AF/AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.
The feasibility primary endpoint was defined as freedom from any AF/AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 3 months, 6 months, 12 months and 36 months respectively after the procedure.
composite of major safety events
Time frame: adverse events occurring within 30 days of the index or reassessment procedures.
The safety endpoint is a composite of major safety events including cardiac tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack (TIA), diaphragmatic paralysis, block, pericarditis, hemolysis, myocardial infarction, PV stenosis, atrioesophageal fistula, and death. The endpoint includes events occurring within 30 days of the index or reassessment procedures.
2 secondary outcomes
AF recurrence
Time frame: freedom from any AF at 3 months, 6 months, 12 months and 36 months respectively after the procedure
AT recurrence
Time frame: freedom from any AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure
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 21 Apr 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) from this study will not be shared publicly due to concerns regarding patient confidentiality and the sensitive nature of medical data. Given the potential risks of identifying participants from detailed clinical information, the data will remain confidential and will not be made available for public sharing. Additionally, the study involves proprietary methodologies and ongoing analyses that are part of the intellectual property of the institution. As such, sharing the IPD at this stage could compromise the integrity of the study's findings and its future applications.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates and PFA-based PVI+PWI alone in people with Non-paroxysmal Atrial Fibrillation, run by Xu Liu at 10 sites in 2 countries.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom from any AF/AT (time frame: freedom from any AF/AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.). The study lists 2 primary outcomes in all. 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 21 Apr 2026.