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Not yet recruitingNCT07880262Updated Oct 22, 2026

Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation

An interventional study of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping in Atrial Fibrillation (AF), sponsored by Xi'an Jiaotong University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

Updated Oct 22, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Atrial Fibrillation (AF)

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 120 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Xi'an Jiaotong University is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Individualized PFA Guided by Substrate Mapping

    Procedure: Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping

Interventions

  • ProcedureIndividualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping

    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.

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What researchers measure

Primary outcomes

  1. Freedom From Atrial Tachyarrhythmia Recurrence

    Time frame: From the end of the 3-month blanking period through 12 months after ablation

Secondary outcomes

  1. Acute Ablation Success Rate

    Time frame: At the end of the ablation procedure, after a 20- to 30-minute waiting period

  2. Atrial Tachyarrhythmia During the Blanking Period

    Time frame: From ablation through 3 months after ablation

  3. Procedure- or PFA-Related Adverse Events

    Time frame: From the start of the ablation procedure through 12 months after ablation

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Study locations

No study locations are listed for this record.

08

Updates

3 registry updates since Sep 25, 2026
Also revised
eligibility
Registered
First appeared on the registry
Oct 19, 2026
Show all 3 updates
  1. Oct 22, 2026
    Eligibility Criteria revised
  2. Oct 21, 2026
    Eligibility Criteria revised
    + 1 other change: identifiers
  3. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07880262
Lead sponsor
Xi'an Jiaotong University
Responsible party
Hongtao Wang (Associate chief physician, Xi'an Jiaotong University) — Principal investigator
First posted
Oct 19, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Oct 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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