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NCT Number: NCT07518966

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Bangjiaxin Ren MD

CONTACT

[email protected]

+86-18983234883

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsed field ablation

Procedure

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

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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