RecruitingPhase 4NCT06765356

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

Sponsor

Vivek Reddy

Enrollment

275 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation Long-standing Persistent Atrial Fibrillation

Summary

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating a newer type of heart procedure called pulsed field ablation (PFA) — specifically a five-spline catheter system — to treat atrial fibrillation (AF), an irregular heart rhythm. Ablation uses energy to destroy the small areas of heart tissue causing the abnormal rhythm. **You may be eligible if...** - You are 18 or older and have been diagnosed with atrial fibrillation (AF) confirmed by an ECG at some point - You have paroxysmal AF (comes and goes) or persistent AF (lasts longer) - You are scheduled for a clinically indicated catheter ablation procedure - You have had symptoms of AF despite medication, or prefer ablation over ongoing drug therapy - Previous ablation for a different heart rhythm condition is permitted **You may NOT be eligible if...** - You have had a prior ablation specifically for atrial fibrillation - You have a mechanical heart valve or certain anatomical conditions that make ablation unsafe - You have a blood clot in your heart (left atrial appendage thrombus) - Your medical condition makes catheter ablation too risky 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 Catheter System

The FARAWAVE PFA Catheter is a sterile, single use, over-the-wire, non-deflectable device that is used with the FARASTAR Catheter Connection Cable and FARASTAR Generator to enable delivery of Pulsed Field Ablation energy for irreversible electroporation. The FARAWAVE PFA Catheter has five (5) variably deployable splines. The five splines are undeployed during insertion and removal and during use can deploy continuously from an undeployed state through a partially deployed ("basket-shaped") configuration to a fully deployed ("flower-shaped") configuration with five petals.

DRUGLow-dose Colchicine

For participants in the colchicine sub-study, 0.3 mg BID Colchicine. Colchicine will be prescribed to the patient starting 5 days prior to ablation. Patient will continue the colchicine for 3 weeks post-ablation.