RecruitingNot ApplicableNCT07444320

Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation


Sponsor

Boston Scientific Corporation

Enrollment

200 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of energy (called pulsed field ablation) delivered through a specialized catheter to treat atrial fibrillation — an irregular heartbeat where the upper chambers of the heart quiver instead of beating normally. Researchers want to see if a new waveform setting on the FARAPULSE device works safely and effectively. **You may be eligible if:** - You are 18 years of age or older - You have been diagnosed with persistent or paroxysmal (comes-and-goes) atrial fibrillation, confirmed by a doctor's note and heart rhythm tests within the past 6 months - You are willing and able to attend all follow-up visits **You may NOT be eligible if:** - Your heart's left upper chamber is significantly enlarged (diameter ≥ 5.5 cm) - You have had a previous ablation or heart surgery for abnormal rhythm (other than specific minor procedures) - You currently have a blood clot in your heart - You have certain heart conditions such as recent heart attack, severe valve disease, or a pacemaker/defibrillator already in place - You have had a stroke or serious bleeding event within the past 6 months - You are pregnant or have severe kidney, liver, or lung disease 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

DEVICEFARAPULSE™ Pulsed Field Ablation (PFA) System

The FARAWAVE™ PFA Catheter will be used to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARASTAR™ Generator will be used in conjunction with the FARAWAVE™ PFA Catheter to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARADRIVE™ Steerable Sheath will be used for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.


Locations(2)

Klinicki Bolnicki Centar Split

Split, Croatia

Na Homolce Hospital

Prague, Czechia

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NCT07444320


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