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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07518966
Enrollment
1200
Registered
2026-04-09
Start date
2025-06-16
Completion date
2027-06-30
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

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. 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

PROCEDUREpulsed field ablation

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Atrial arrhythmiasfrom 3 months to 12 months post-ablationIncluding 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026