RecruitingNot ApplicableNCT06510556

Feasibility Study of the FARAFLEX Mapping and PFA System

Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation

Sponsor

Boston Scientific Corporation

Enrollment

250 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Persistent Atrial Fibrillation Paroxysmal AF

Summary

The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study is testing a new cardiac mapping and pulse field ablation (PFA) system called FARAFLEX to treat atrial fibrillation (AFib) — an irregular heart rhythm. Ablation uses controlled energy to destroy small areas of heart tissue causing the abnormal electrical signals. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with symptomatic atrial fibrillation that is either persistent (lasting more than 7 days) or paroxysmal (comes and goes) - You are willing to attend all follow-up visits and assessments **You may NOT be eligible if...** - Your left atrium (upper left heart chamber) is significantly enlarged (≥5.5 cm in diameter or volume >100 mL) - You have had a prior ablation for AFib - You have certain heart conditions such as severe valve disease, heart failure, or recent heart attack - You have a blood clot in the heart or a contraindication to blood thinners - You are pregnant or have other serious conditions 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEFARAFLEX Ablation Treatment

Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using the investigational Boston Scientific FARAFLEX Mapping and Pulse Field Ablation (PFA) System, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator.

DEVICECommercial Sub-study Treatment

Subjects scheduled to undergo endocardial mapping and ablation therapy in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation. Using a commercially available PFA system, ablation of the pulmonary veins will be performed; ablation of the left atrial posterior wall, mitral isthmus (MI), LA roof line and/or cavo-tricuspid isthmus (CTI) is at the discretion of the investigator, per the selected catheter's IFU and in accordance with the guidelines.