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

NCT07518966 | Recruiting

• 1 other identifier: 2022(302)
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• Atrial arrhythmias

  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

Study Arms (1)

Pulsed field ablation group

Procedure: pulsed field ablation

Interventions

pulsed field ablation PROCEDURE

The patient underwent the ablation procedure using the pentaspline pulsed field ablation system.

Pulsed field ablation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)