Association Between Early Recurrence and Long-Term Recurrence After Pulsed Field Ablation for Atrial Fibrillation: Prospective Real-World Evidence From China

April 11, 2026 updated by: Bangjiaxin Ren, West China Hospital

The goal of this observational study is to analyze the predictive value of early recurrence within different time windows for late recurrence, ultimately providing evidence-based support for defining the blanking period after pulsed field ablation and stratifying recurrence risk, with the goal of transforming clinical management strategies following pulsed field ablation. The main questions it aims to answer are:

  1. Employ big data analysis methods to develop a risk stratification tool for atrial fibrillation;
  2. Identify high-risk prognostic indicators for atrial fibrillation and establish early assessment models for short-term and long-term prognosis.

Participants will undergo pulsed field ablation for the treatment of atrial fibrillation and will receive structured follow-ups at 1, 3, 6, and 12 months post-ablation. At each follow-up, a 24-hour Holter monitor will be performed to systematically assess the recurrence of atrial arrhythmias and the atrial arrhythmia burden.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutively selected patients with atrial fibrillation who underwent pulsed field ablation (PFA) in the Department of Cardiology at West China Hospital of Sichuan University from June 2025 to June 2026. Patients were screened strictly in accordance with the inclusion and exclusion criteria to enroll eligible participants as study subjects.

Description

Inclusion Criteria:

  • Patients aged ≥18 years
  • Study participants diagnosed with atrial fibrillation (AF) and scheduled to undergo pulsed field ablation
  • Study participants undergoing their first ablation procedure for AF

Exclusion Criteria:

  • Study participants with any known contraindications to the pulsed field ablation system, anticoagulation therapy, use of contrast agents, or atrial fibrillation ablation
  • Those who have previously undergone atrial fibrillation ablation, or have severe mitral stenosis, valve replacement, or various cardiac surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulsed field ablation group
Procedure: pulsed field ablation
The patient underwent the ablation procedure using the pentaspline pulsed field ablation system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial arrhythmias
Time Frame: from 3 months to 12 months post-ablation
Including atrial fibrillation, atrial flutter, and atrial tachycardia, recorded as ≥10 seconds on a 12-lead electrocardiogram or ≥30 seconds on ambulatory electrocardiography (including single-lead patch devices).
from 3 months to 12 months post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2025

Primary Completion (Estimated)

June 16, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022(302)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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