Atrial Fibrillation (AF)NCT07880262
Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation
A study testing Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping in people with Atrial Fibrillation (AF), run by Xi'an Jiaotong University.
Trial summary
This study will adopt a prospective, single-center, single-arm research design, enrolling 120 patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation for the first time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older; no gender restriction.
- Diagnosis of paroxysmal or persistent atrial fibrillation confirmed by electrocardiogram or ambulatory electrocardiogram, and undergoing the first cardiac ablation procedure.
- Willing and able to provide informed consent and comply with all study follow-up requirements.
Who cannot join
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
- Previous left atrial ablation or cardiac surgery involving the left atrium, including left atrial appendage occlusion.
- Left atrial or left atrial appendage thrombus.
- Pulmonary vein stenosis or previous pulmonary vein stent implantation.
- Previous atrial septal repair or atrial myxoma.
- Left atrial anterior-posterior diameter ≥ 50 mm.
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- Left ventricular ejection fraction (LVEF) < 40%.
- New York Heart Association (NYHA) functional class III or IV.
- Cerebrovascular disease within the past 3 months, including stroke or transient ischemic attack.
- Cardiovascular events within the past 3 months, including acute myocardial infarction, coronary intervention, coronary artery bypass grafting, artificial valve replacement or repair, or atrial or ventricular incision surgery.
- Acute or severe systemic infection.
- Severe liver or kidney disease.
- Obvious bleeding tendency or hematological disease.
- Malignant tumor or end-stage disease.
- Rheumatic heart disease.
- Pregnancy or breastfeeding, or inability to use contraception during the study.
- Concurrent participation in another drug or device clinical trial.
- Any other abnormality or disease that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
About this study
Official title: Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation: A Prospective, Single-Center, Single-Arm Study
This study will adopt a prospective, single-center, single-arm research design, enrolling 120 patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation for the first time. Individualized pulsed electrical field pulmonary vein isolation will be performed under the guidance of pulmonary vein vestibular stromal mapping. By recording the distribution characteristics of abnormal stroma in the pulmonary vein vestibule, the guidance situation of the ablation strategy based on the mapping results, surgical and ablation parameters, immediate pulmonary vein isolation effect, perioperative complications, and the 12-month recurrence-free survival rate of atrial arrhythmias after surgery, the feasibility, effectiveness and safety of this ablation strategy will be evaluated, and the relationship between the characteristics of pulmonary vein vestibular stroma and postoperative recurrence will be explored. This will provide more clinical experience and data support for individualized ablation under the guidance of pulmonary vein vestibular stromal mapping.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate MappingProcedure or surgery
Before ablation, electroanatomic voltage mapping of the left atrium and pulmonary vein antra will be performed. Low-voltage areas will be identified using prespecified thresholds according to the rhythm during mapping: <0.5 mV during sinus rhythm and <0.3 mV during atrial fibrillation. Mapping findings will guide an individualized pulmonary vein isolation strategy, including the ablation boundary and segmental lesion delivery, according to the study protocol. Pulsed field energy will be delivered using the PFA catheter and system specified in the protocol. Repeat mapping will be performed 20-30 minutes after ablation to assess the lesion set and identify residual conduction or reconnection.
| Study group | Role | What they receive |
|---|---|---|
| Individualized PFA Guided by Substrate Mapping | Experimental | Not described Receives: Procedure: Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Atrial Tachyarrhythmia Recurrence
Measured: From the end of the 3-month blanking period through 12 months after ablation
Secondary outcomes (3)
Acute Ablation Success Rate
Measured: At the end of the ablation procedure, after a 20- to 30-minute waiting period
Atrial Tachyarrhythmia During the Blanking Period
Measured: From ablation through 3 months after ablation
Procedure- or PFA-Related Adverse Events
Measured: From the start of the ablation procedure through 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongtao Wang, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880262
- Sponsor's protocol ID
- 2026-344
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation: A Prospective, Single-Center, Single-Arm Study
- ClinicalTrials.gov ID
- NCT07880262
- Acronym / sponsor ID
- 2026-344
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Oct 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.
This study will adopt a prospective, single-center, single-arm research design, enrolling 120 patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation for the first time. Individualized pulsed electrical field pulmonary vein isolation will be performed under the guidance of pulmonary vein vestibular stromal mapping. By recording the distribution characteristics of abnormal stroma in the pulmonary vein vestibule, the guidance situation of the ablation strategy based on the mapping results, surgical and ablation parameters, immediate pulmonary vein isolation effect, perioperative complications, and the 12-month recurrence-free survival rate of atrial arrhythmias after surgery, the feasibility, effectiveness and safety of this ablation strategy will be evaluated, and the relationship between the characteristics of pulmonary vein vestibular stroma and postoperative recurrence will be explored. This will provide more clinical experience and data support for individualized ablation under the guidance of pulmonary vein vestibular stromal mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized PFA Guided by Substrate Mapping | Experimental | Procedure: Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older; no gender restriction.
- Diagnosis of paroxysmal or persistent atrial fibrillation confirmed by electrocardiogram or ambulatory electrocardiogram, and undergoing the first cardiac ablation procedure.
- Willing and able to provide informed consent and comply with all study follow-up requirements.
Key exclusion criteria (18 listed)
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
- Previous left atrial ablation or cardiac surgery involving the left atrium, including left atrial appendage occlusion.
- Left atrial or left atrial appendage thrombus.
- Pulmonary vein stenosis or previous pulmonary vein stent implantation.
- Previous atrial septal repair or atrial myxoma.
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 |
|---|---|---|
| Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate MappingBefore ablation, electroanatomic voltage mapping of the left atrium and pulmonary vein antra will be performed. Low-voltage areas will be identified using prespecified thresholds according to the rhythm during mapping: <0.5 mV during sinus rhythm and <0.3 mV during atrial fibrillation. Mapping findings will guide an individualized pulmonary vein isolation strategy, including the ablation boundary and segmental lesion delivery, according to the study protocol. Pulsed field energy will be delivered using the PFA catheter and system specified in the protocol. Repeat mapping will be performed 20-30 minutes after ablation to assess the lesion set and identify residual conduction or reconnection. | Procedure or surgery | Individualized PFA Guided by Substrate Mapping |
Primary outcome
Freedom From Atrial Tachyarrhythmia Recurrence
Time frame: From the end of the 3-month blanking period through 12 months after ablation
3 secondary outcomes
Acute Ablation Success Rate
Time frame: At the end of the ablation procedure, after a 20- to 30-minute waiting period
Atrial Tachyarrhythmia During the Blanking Period
Time frame: From ablation through 3 months after ablation
Procedure- or PFA-Related Adverse Events
Time frame: From the start of the ablation procedure through 12 months after ablation
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 22 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping in people with Atrial Fibrillation (AF), run by Xi'an Jiaotong University.
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 3 inclusion and 18 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Atrial Tachyarrhythmia Recurrence (time frame: From the end of the 3-month blanking period through 12 months after ablation). 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 22 Oct 2026.