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NCT Number: NCT06739512

Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation

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.

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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

  • 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.

Treatment and study plan

Extensive Electro-Anatomical Guided Ablation

Procedure

Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.

Anatomical Guided Ablation

Procedure

Ablation using PFA. Guided by anatomical landmarks without potential mapping

Electrogram Guided Ablation

Procedure

Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.

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 and Quality of Life Enhancement.

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

    Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).

  3. 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

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Dec 18, 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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