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

NCT ID: NCT06745167

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Keywords

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atrial fibrillation pulsed field ablation radiofrequency ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pulsed field ablation

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation alone

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein College of Medicine and Montefiore Medical Center

UNKNOWN

Sponsor Role collaborator

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

UNKNOWN

Sponsor Role collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Yuhuan Second People's Hospital

UNKNOWN

Sponsor Role collaborator

Changshu Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The PLA Navy Anqing Hospital

UNKNOWN

Sponsor Role collaborator

Jinan People's Hospital

UNKNOWN

Sponsor Role collaborator

Xuzhou Central Hospital

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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No. 241, West Huaihai Road

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xu Liu, MD

Role: CONTACT

Phone: +86 021-22200000

Email: [email protected]

Facility Contacts

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Xu Liu, MD

Role: primary

Other Identifiers

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EXT-III

Identifier Type: -

Identifier Source: org_study_id