Menu
Not yet recruiting NCT06739512

Pulsed Field Ablation in Three Different Substrate Ablation Strategies for 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: Extensive Electro-Anatomical Guided Ablation, Anatomical Guided Ablation, Electrogram Guided Ablation.
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 →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial

Overview

This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.

Interventions

  • Procedure Extensive Electro-Anatomical Guided Ablation
    Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.
  • Procedure Anatomical Guided Ablation
    Ablation using PFA. Guided by anatomical landmarks without potential mapping
  • Procedure Electrogram Guided Ablation
    Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.

Primary outcome measures

  • Freedom from Atrial Arrhythmia Recurrence at 12 Months [Time frame: 12 months after ablation procedure]
Secondary outcome measures (3)
  • Procedural Safety [Time frame: From enrollment to completion of follow-up（at least 12 months）]
  • Symptom Relief and Quality of Life Enhancement. [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

  • Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
  • 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: NCT06739512 · EXT-II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗