NCT06745167

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

November 25, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 20, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 25, 2024

Last Update Submit

December 19, 2024

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillationpulsed field ablationradiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Freedom from Atrial Arrhythmia Recurrence at 12 Months

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

    12 months after ablation procedure

Secondary Outcomes (4)

  • Procedural Safety

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

  • Symptom Relief (EHRA scores)

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

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

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

  • Atrial Fibrillation Burden Reduction

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

Study Arms (2)

Pulsed field ablation

EXPERIMENTAL

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

Radiofrequency Ablation

ACTIVE COMPARATOR

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

Interventions

Pulsed field ablationPROCEDURE

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.

Pulsed field ablation
Radiofrequency ablation alonePROCEDURE

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

Radiofrequency Ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 241, West Huaihai Road

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Xu Liu

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Liu, MD

CONTACT

+86 021-22200000drliuxu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 20, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

CN(1)