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Doctors & patients are saying about 'Beat Your A-Fib'...


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ADVENT Trial of Pulsed Field Ablation (PFA) for Paroxysmal A-Fib! PFA a True Game Changer

Fundamentally different from traditional methods for cardiac ablation, I expect the FARAPULSE Pulsed Field Ablation (PFA) will change the way catheter ablations are done and will become an innovative and most effective treatment option for Atrial Fibrillation.

U.S. Trial of Pulsed Field Ablation (PFA)

The U.S. trial of the FARAPULSE Pulsed Field Ablation (PFA) system is underway. The first patients in the ADVENT Trial were treated at New York’s Mount Sinai Hospital by Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services.

” I believe PFA will define a new era in the ablation of AF and possibly other arrhythmias.” – Dr. Pierre Jais, French Bordeaux LIRYC

The ADVENT Trial is a prospective randomized pivotal trial of the FARAPULSE Pulsed Field Ablation System compared with standard of care ablation in patients with paroxysmal atrial fibrillation.

“…We look forward to how our study can move adoption of this procedure forward,” said Dr. Vivek Y. Reddy.

ADVENT Trial is Recruiting: You May Quality

There are 37 study locations participating in the ADVENT Trial (see the list). Recruiting is underway and you may qualify.

Key inclusion criteria: Patients are required to meet all the following inclusion criteria to participate in this study (there are also exclusion criteria):

• Age 18-75
• Paroxysmal atrial fibrillation
• Anti-arrhythmic drug failed for efficacy or intolerance

Learn more about the ADVENT Trial on the FARAPULSE website. Prospective patients of The ADVENT Trial should contact their physician.

How PFA Works

As an emerging technology, there are many concepts and treatment strategies that will be brand new to you (they were for me).

Pulsed Field Ablation (PFA) is fundamentally different from traditional methods for cardiac ablation. PFA is very tissue selective.

PFA is Tissue Selective; Green labels are Preserved tissue; Red label is Ablated tissue

Through a process called irreversible electroporation, cardiac tissue targeted for ablation is rendered electrically inactive while collateral tissues are spared.

Unlike traditional thermal methods, PFA works on the selected cell types while leaving others alone.

Based on European clinical trials, these electric fields have proven very effective in durably “silencing” abnormal heart signals, while reducing the risk of damage to other nearby tissues.

For more on how PFA works, see my report: 2020 AF Symposium Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.

First Approved in Europe

In March 2021, Pulsed Field Ablation (PFA) from FARAPULSE, Inc. received CE Mark approval and can now market in the Europeans Union and other CE Mark countries. FARAPULSE plans to launch by first partnering with a select number of physicians, then move to a broader rollout.

Boston Scientific has expanded investment in FARAPULSE, Inc. and secured an exclusive option to acquire it.

Resources for this article
• Reddy VY, et ak. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28. PMID: 33933412.

• First AF Patients Treated With Farapulse Pulsed Field Ablation System. DAIC.com  MARCH 03, 2021. May-June 2021 Issue. https://www.dicardiology.com/content/first-af-patients-treated-farapulse-pulsed-field-ablation-system

• The FARAPULSE ADVENT PIVOTAL Trial (ADVENT). ClinicalTrial.gov https://www.clinicaltrials.gov/ct2/show/NCT04612244?term=NCT04612244&draw=2&rank=1

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