NCT07880262Not yet recruiting
Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Xi'an Jiaotong University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07880262
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Nov 2026 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrial ablation or cardiac surgery involving the left atrium, including left atrial appendage occlusion.
- Pulmonary vein stenosis or previous pulmonary vein stent implantation.
- Previous atrial septal repair or atrial myxoma.
- Concurrent participation in another drug or device clinical trial.
Other illness
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
- 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.
- Any other abnormality or disease that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
Lab values
- Left ventricular ejection fraction (LVEF) \< 40%.
Other
- Left atrial or left atrial appendage thrombus.
- Left atrial anterior-posterior diameter ≥ 50 mm.
- Pregnancy or breastfeeding, or inability to use contraception during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.