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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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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

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.
Show all 18Show fewer
  • 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.

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 groups in NCT07880262
Study groupRoleWhat they receive
Individualized PFA Guided by Substrate MappingExperimentalNot 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.

  1. Freedom From Atrial Tachyarrhythmia Recurrence

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

Secondary outcomes (3)

  1. Acute Ablation Success Rate

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

  2. Atrial Tachyarrhythmia During the Blanking Period

    Measured: From ablation through 3 months after ablation

  3. 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.

  1. First posted19 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

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)
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

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