Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

NCT ID: NCT06791629

Last Updated: 2025-01-24

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

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2027-02-15

Brief Summary

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This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.

Participants will:

Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.

Detailed Description

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Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.

In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.

Conditions

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Persistent Atrial Fibrillation Radiofrequency Catheter Ablation Pulsed Field Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency Ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type DEVICE

Patients will be treated with radiofrequency ablation for atrial fibrillation.

Pulsed Field Ablation

Group Type EXPERIMENTAL

Pulsed Field Ablation

Intervention Type DEVICE

Patients will be treated with pulsed field ablation for atrial fibrillation.

Interventions

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Pulsed Field Ablation

Patients will be treated with pulsed field ablation for atrial fibrillation.

Intervention Type DEVICE

Radiofrequency Ablation

Patients will be treated with radiofrequency ablation for atrial fibrillation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-80 years
* Patients with non-valvular persistent atrial fibrillation undergoing their first catheter ablation (AF duration: 3 months to 3 years)
* Left atrial diameter on parasternal long-axis view of echocardiogram \< 50 mm
* Agree to be randomly assigned to the ablation strategy and able to follow up

Exclusion Criteria

* Atrial fibrillation due to reversible causes
* LVEF \< 30%
* Severe congenital heart disease
* Severe liver or kidney dysfunction (eGFR \< 15, Child-Pugh grade 3), or history of dialysis
* History of cardiac surgery, such as coronary artery bypass grafting, mechanical valve or prosthetic valve replacement
* History of pacemaker implantation, left atrial appendage closure, or patent foramen ovale closure
* Contraindications to oral anticoagulation
* Contraindications to right or left heart catheterization
* Pregnancy
* Life expectancy \< 1 year (e.g., advanced malignancy, end-stage renal disease)
* Currently enrolled in another trial evaluating medical devices or drugs
* Other situations where the investigator determines the subject is unsuitable for the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Deyong Long

Role: CONTACT

+86 135 2295 8166

Facility Contacts

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Deyong Long

Role: primary

+86 13522958166

Other Identifiers

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2025-PeAF ablation

Identifier Type: -

Identifier Source: org_study_id

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