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Not yet recruiting NCT06745167

Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation

No phase Interventional 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, Radiofrequency ablation alone.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: 18 years — 80 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 →

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Official title

Comparative Efficacy and Safety of Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in the Treatment of Persistent Atrial Fibrillation: A Randomized Controlled Trial

Overview

This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.

Interventions

  • Procedure Pulsed field ablation
    Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation.
  • Procedure Radiofrequency ablation alone
    Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation

Primary outcome measures

  • Freedom from Atrial Arrhythmia Recurrence at 12 Months [Time frame: 12 months after ablation procedure]
Secondary outcome measures (4)
  • Procedural Safety [Time frame: From enrollment to completion of follow-up（at least 12 months）]
  • Symptom Relief (EHRA scores) [Time frame: From enrollment to completion of follow-up（at least 12 months）]
  • Quality of Life (Short Form 36 Health Survey). [Time frame: From enrollment to completion of follow-up（at least 12 months）]
  • Atrial Fibrillation Burden Reduction [Time frame: From enrollment to completion of follow-up（at least 12 months）]

Eligibility criteria

Inclusion criteria

1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.

Exclusion criteria

  • Major valvular diseases needing surgical intervention.
  • Presence of a left atrial thrombus on recent imaging.
  • Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
  • Current Severe Infection.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • No. 241, West Huaihai Road — Shanghai

Identifiers

NCT: NCT06745167 · EXT-III

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗