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

NCT06739512 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-12-18

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)

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.

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

  • Jinan People's Hospital

    collaborator UNKNOWN

  • Xuzhou Central Hospital

    collaborator OTHER

  • The PLA Navy Anqing Hospital

    collaborator UNKNOWN

  • Shanghai Chest Hospital

    lead OTHER

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
2024-12-25
Primary Completion
2025-12-01
Completion
2026-12-01

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 NCT06739512 on ClinicalTrials.gov