Persistent Atrial FibrillationEGM-PFANCT06729866
EGM Guided PFA for PerAF
A study testing electrogram guided pulse field ablation in people with Persistent Atrial Fibrillation, run by Xu Liu at 1 site in China.
Trial summary
Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- electrogram guided pulse field ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
- Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent
- ECG-documented episode of persistent AF lasting longer than 7 days
- Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
- Patients who are ≥ 18 years
- Patient participation requirements:
- Is willing and capable of providing Informed Consent to undergo study procedures
- Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Who cannot join
- AF that is:
- Paroxysmal (longest AF episode < 7days)
- Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
- Any of the following cardiac conditions:
- Clinically significant arrhythmias other than AF, AFL or AT
Show all 33Show fewer
- NYHA Class IV CHF
- Atrial or ventricular septal defect closure
- Atrial myxoma
- History of congenital heart disease with any residual anatomic or conduction abnormality
- Any of the following within 3 months of enrollment:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
- Heart failure hospitalization
- Stroke or TIA
- Clinically significant bleeding
- Pericarditis or pericardial effusion
- Left atrial thrombus
- History of blood clotting or bleeding abnormalities.
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Sensitivity to contrast media not controlled by premedication
- Women of childbearing potential who are pregnant, lactating or not using birth control
- 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 to
- Body mass index (BMI) > 40 transplant
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
- Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- Active malignancy or history of treated cancer within 24 months of enrollment
- Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- Clinically significant infection
- Predicted life expectancy less than one year
- Current or anticipated enrollment in any other clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrogram Guided Pulse Field Ablation for Persistent Atrial Fibrillation
Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.
Read the detailed description
Multiple studies have confirmed that pulse field ablation (PFA) demonstrates superior safety and efficacy in pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF). However, the application of PFA in persistent atrial fibrillation (PerAF) remains in the exploratory stages. The efficacy and safety of PFA across various ablation strategies require a comprehensive evaluation. Notably, electrogram (EGM) guided PFA ablation for persistent atrial fibrillation has not yet been reported in the literature.
In the investigators' previous study on radiofrequency ablation for PerAF, the investigators observed that EGM guided ablation yielded a high success rate. Furthermore, the investigators' recent research has confirmed that intraoperative termination of atrial fibrillation using EGM guided ablation is associated with favorable long-term outcomes in patients with PerAF.
The investigators aim to explore the preliminary application of EGM guided pulse field ablation (PFA) in persistent atrial fibrillation.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- electrogram guided pulse field ablation
- Keywords
- eletrogram guided ablation, pulse field ablation, persistent atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrogram guided pulse field ablationProcedure or surgery
In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.
| Study group | Role | What they receive |
|---|---|---|
| Electrogram guided pulse field ablation | Experimental | In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found. Receives: Procedure: electrogram guided pulse field ablation |
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 and 12 months respectively after the procedure.
Measured: freedom from any AF/AT at 3 months, 6 months and 12 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 and 12 months respectively
Measured: freedom from any AF at 3 months, 6 months and 12 months respectively after the procedure;
AT recurrence
Secondary outcomes included: any documented AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment at 3 months, 6 months and 12 months respectively.
Measured: freedom from any AT at 3 months, 6 months and 12 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 posted11 Dec 2024
- Study start20 Sep 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (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 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
- Not applicable
- Intervention model
- Single group
- Model description
- In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729866
- Sponsor's protocol ID
- EGM-PFA for PerAF
- Acronym
- EGM-PFA
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li K, Di Biase L, Qin M, Wu S, Zhang X, Liu X, Hou X. Electrogram-guided pulsed field ablation for persistent atrial fibrillation: A prospective cohort study. Heart Rhythm. 2026 Mar 10:S1547-5271(26)02113-2. doi: 10.1016/j.hrthm.2026.03.1878. Online ahead of print.
PubMed 41819245
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrogram Guided Pulse Field Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06729866
- Acronym / sponsor ID
- EGM-PFA / EGM-PFA for PerAF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- eletrogram guided ablation, pulse field ablation, persistent atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Xu LiuUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (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.
Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.
Detailed description
Multiple studies have confirmed that pulse field ablation (PFA) demonstrates superior safety and efficacy in pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF). However, the application of PFA in persistent atrial fibrillation (PerAF) remains in the exploratory stages. The efficacy and safety of PFA across various ablation strategies require a comprehensive evaluation. Notably, electrogram (EGM) guided PFA ablation for persistent atrial fibrillation has not yet been reported in the literature.
In the investigators' previous study on radiofrequency ablation for PerAF, the investigators observed that EGM guided ablation yielded a high success rate. Furthermore, the investigators' recent research has confirmed that intraoperative termination of atrial fibrillation using EGM guided ablation is associated with favorable long-term outcomes in patients with PerAF.
The investigators aim to explore the preliminary application of EGM guided pulse field ablation (PFA) in persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.
| Arm | Type | Receives |
|---|---|---|
| Electrogram guided pulse field ablation | Experimental | Procedure: electrogram guided pulse field ablationIn persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
- Patients who are ≥ 18 years
- Patient participation requirements:
Key exclusion criteria (33 listed)
- AF that is:
- Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
- Any of the following cardiac conditions:
- Any of the following within 3 months of enrollment:
- History of blood clotting or bleeding abnormalities.
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 |
|---|---|---|
| electrogram guided pulse field ablationIn persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found. | Procedure or surgery | Electrogram guided pulse field ablation |
Primary outcome
freedom from any AF/AT
Time frame: freedom from any AF/AT at 3 months, 6 months and 12 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 and 12 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 and 12 months respectively after the procedure;
AT recurrence
Time frame: freedom from any AT at 3 months, 6 months and 12 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 4 Jun 2025.
- Derived from this study: PubMed 41819245Li K, Di Biase L, Qin M, Wu S, Zhang X, Liu X, Hou X. Electrogram-guided pulsed field ablation for persistent atrial fibrillation: A prospective cohort study. Heart Rhythm. 2026 Mar 10:S1547-5271(26)02113-2. doi: 10.1016/j.hrthm.2026.03.1878. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrogram guided pulse field ablation in people with Persistent Atrial Fibrillation, run by Xu Liu at 1 site 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 8 inclusion and 33 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 4 Jun 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 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?
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 and 12 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?
On the ClinicalTrials.gov record for NCT06729866, 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 4 Jun 2025.