MARLBOROUGH, Mass., Dec. 28,
2023 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) has initiated the AVANT GUARD clinical trial to
evaluate the safety and effectiveness of the FARAPULSE™ Pulsed
Field Ablation (PFA) System* as a first-line treatment for
persistent atrial fibrillation (AF), the only trial to study the
use of PFA as frontline therapy in patients with this form of AF.
Outcomes of ablation with the FARAPULSE PFA System – a nonthermal
treatment in which electric fields selectively ablate heart tissue
– will be compared to outcomes following use of anti-arrhythmic
drug (AAD) therapy, which is commonly prescribed for patients
living with persistent AF.
Unlike paroxysmal AF, which describes symptoms that last for
seven days or fewer, persistent AF is a sustained arrhythmia that
lasts for more than a week1. Early treatment of
persistent AF can reduce the risk of blood clots, stroke, and
heart failure, and may prevent the disease from becoming permanent.
Patients are often treated with AADs as frontline therapy for heart
rhythm maintenance, though some can experience adverse effects and
limited efficacy. Cardiac ablation is a potential alternative
interventional strategy for those living with persistent AF.
"With nearly 40,000 patients treated to date in clinical and
commercial settings, the FARAPULSE PFA System continues to
demonstrate a promising safety and effectiveness profile, upon
which this study seeks to build," said Dr. Brad Sutton, chief medical officer, AF
Solutions, Boston Scientific. "The AVANT GUARD trial is exciting in
that it has the potential to change clinical practice by advancing
the therapy to be utilized as an earlier treatment for persistent
AF, which may lead to better long-term outcomes and establish the
FARAPULSE PFA System as the preferred method for treating the
disease."
The randomized AVANT GUARD trial will enroll more than 500
patients diagnosed with persistent AF at up to 75 sites globally.
Patients in the study will be randomized to undergo pulmonary vein
isolation (PVI) and left atrial posterior wall ablation using the
FARAPULSE PFA System, or receive AAD treatment, and followed for
three years. The trial will evaluate the outcomes of therapy
provided with the FARAPULSE PFA System versus AADs, including
device-or procedure-related adverse events, the rates of freedom
from AF, atrial flutter, or atrial tachycardia, as well as AF
burden – a measurement of the amount of AF an individual
experiences.
All patients in the trial will also be inserted with the Boston
Scientific LUX-Dx™ Insertable Cardiac Monitor. This device
simplifies the monitoring process for patients by automatically
capturing and transmitting arrhythmia episode data, and is designed
to detect recurrence of cardiac arrhythmias and assess AF burden by
providing continuous rhythm monitoring.
This week, the Cleveland Clinic enrolled the first patient in
the AVANT GUARD trial, overseen by Dr. Oussama Wazni, vice chair of cardiovascular
medicine and section head, Cardiac Electrophysiology and Pacing,
Cleveland Clinic, who is also serving as the lead investigator of
the trial.
Earlier this year, clinical trial data presented demonstrated
the FARAPULSE PFA System is noninferior to standard-of-care
therapies for the treatment of paroxysmal AF, with superior
efficiency, while additional real-world data from more than 17,000
patients demonstrated continued real-world safety, efficacy and
efficiency of the system. Boston Scientific also completed
enrollment in the first phase of the ADVANTAGE AF clinical trial in
the third quarter of 2023, which is studying the system for the
treatment of patients with drug refractory symptomatic persistent
AF, and commenced enrollment in an extension arm of the study to
evaluate the safety and effectiveness of adjunctive use of the
FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablations,
a procedure used to treat atrial flutter.
The company now anticipates U.S. Food and Drug Administration
approval of the FARAPULSE PFA System in the first quarter of 2024.
Additional information about clinical evidence supporting the
device can be found here.
*Caution: Investigational Device. Limited by Federal (or US) law
to investigational use only. Not available for sale.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology leader
for more than 40 years, we advance science for life by providing a
broad range of high performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more
information, visit www.bostonscientific.com and connect on Twitter
and Facebook.
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CONTACTS:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Lauren Tengler
Investor Relations
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BSXInvestorRelations@bsci.com
1 https://doi.org/10.1161/CIR.0000000000001193.
Circulation. 2023;0
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SOURCE Boston Scientific Corporation