RecruitingNot ApplicableNCT07106970

PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)

Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial


Sponsor

Boston Scientific Corporation

Enrollment

640 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to treat persistent atrial fibrillation (a-fib) — an irregular heart rhythm that lasts more than 3 months — using a procedure called catheter ablation. One approach targets only the pulmonary veins (PVI alone), while the other also creates additional "line" ablations in the heart. The goal is to find out which approach better keeps a-fib from coming back. **You may be eligible if:** - You are between 18 and 80 years old - You have symptomatic, persistent atrial fibrillation (continuous a-fib for more than 90 days) - Your a-fib symptoms include palpitations, fatigue, shortness of breath, or fainting - At least one medication to control a-fib has failed or you cannot tolerate it - You are scheduled for your first catheter ablation procedure **You may NOT be eligible if:** - You have had previous catheter ablation for atrial fibrillation - You have permanent a-fib or other types of ablation already done - You have significant structural heart disease or other conditions that make ablation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELinear ablation

Linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion.

PROCEDUREPVI alone

Undergo PVI with the study device


Locations(1)

Beijing Anzhen Hospital, affiliated to Capital Medical University

Beijing, China

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NCT07106970


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