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

NCT06745167 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)

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

Sponsors & Collaborators

  • Albert Einstein College of Medicine and Montefiore Medical Center

    collaborator UNKNOWN

  • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator UNKNOWN

  • Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Yuhuan Second People's Hospital

    collaborator UNKNOWN

  • Changshu Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • The PLA Navy Anqing Hospital

    collaborator UNKNOWN

  • Jinan People's Hospital

    collaborator UNKNOWN

  • Xuzhou Central Hospital

    collaborator OTHER

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Xu Liu · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745167 on ClinicalTrials.gov