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NCT Number: NCT06745167

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

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.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pulsed field ablation

Procedure

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.

Radiofrequency ablation alone

Procedure

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 outcomes

  1. Freedom from Atrial Arrhythmia Recurrence at 12 Months

    Time frame: 12 months after ablation procedure

    Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.

Secondary outcomes

  1. Procedural Safety

    Time frame: From enrollment to completion of follow-up（at least 12 months）

    Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis.

  2. Symptom Relief (EHRA scores)

    Time frame: From enrollment to completion of follow-up（at least 12 months）

    Improvement in clinical symptoms (EHRA scores)

  3. Quality of Life (Short Form 36 Health Survey).

    Time frame: From enrollment to completion of follow-up（at least 12 months）

    quality of life measurements (Short Form 36 Health Survey).

  4. Atrial Fibrillation Burden Reduction

    Time frame: From enrollment to completion of follow-up（at least 12 months）

    Reduction in atrial fibrillation burden assessed through follow-up evaluations.

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Liu, MD

CONTACT

[email protected]

+86 021-22200000

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Albert Einstein College of Medicine and Montefiore Medical Center
  • Changshu Hospital of Traditional Chinese Medicine
  • Jinan People's Hospital
  • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
  • Shandong University of Traditional Chinese Medicine
  • The PLA Navy Anqing Hospital
  • Xuzhou Central Hospital
  • Yuhuan Second People's Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

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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