Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
NCT ID: NCT06791629
Last Updated: 2025-01-24
Study Results
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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NOT_YET_RECRUITING
NA
700 participants
INTERVENTIONAL
2025-02-15
2027-02-15
Brief Summary
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Participants will:
Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency Ablation
Radiofrequency Ablation
Patients will be treated with radiofrequency ablation for atrial fibrillation.
Pulsed Field Ablation
Pulsed Field Ablation
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.
Radiofrequency Ablation
Patients will be treated with radiofrequency ablation for atrial fibrillation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-PeAF ablation
Identifier Type: -
Identifier Source: org_study_id
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