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Recruiting NCT07518966

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

Observational Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pulsed field ablation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Atrial arrhythmias [Time frame: from 3 months to 12 months post-ablation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT07518966 · 2022(302)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗