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

December 19, 2024 updated by: Xu Liu, Shanghai Chest Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • No. 241, West Huaihai Road
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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, aiming to target all potential arrhythmic substrates.
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.
Active Comparator: Radiofrequency Ablation
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, aiming to target all potential arrhythmic substrates.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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）
Reduction in atrial fibrillation burden assessed through follow-up evaluations.
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）
Improvement in clinical symptoms (EHRA scores)
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）
quality of life measurements (Short Form 36 Health Survey).
From enrollment to completion of follow-up（at least 12 months）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

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

Investigators

  • Principal Investigator: Xu Liu, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXT-III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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