AVANT GUARD Scientific Trial
Boston Scientific Company (NYSE: BSX) has initiated the AVANT GUARD medical trial to guage the protection and effectiveness of the FARAPULSE™ Pulsed Discipline Ablation (PFA) System* as a first-line remedy for persistent atrial fibrillation (AF), the one trial to review using PFA as frontline remedy in sufferers with this type of AF. Outcomes of ablation with the FARAPULSE PFA System – a nonthermal remedy wherein electrical fields selectively ablate coronary heart tissue – will probably be in comparison with outcomes following use of anti-arrhythmic drug (AAD) remedy, which is often prescribed for sufferers residing with persistent AF.
Not like paroxysmal AF, which describes signs that final for seven days or fewer, persistent AF is a sustained arrhythmia that lasts for greater than every week1. Early remedy of persistent AF can scale back the chance of blood clots, stroke, and coronary heart failure, and should forestall the illness from changing into everlasting. Sufferers are sometimes handled with AADs as frontline remedy for coronary heart rhythm upkeep, although some can expertise opposed results and restricted efficacy. Cardiac ablation is a possible various interventional technique for these residing with persistent AF.
40,000 Sufferers Handled to Date
“With almost 40,000 sufferers handled so far in medical and industrial settings, the FARAPULSE PFA System continues to show a promising security and effectiveness profile, upon which this research seeks to construct,” mentioned Dr. Brad Sutton, chief medical officer, AF Options, Boston Scientific. “The AVANT GUARD trial is thrilling in that it has the potential to alter medical follow by advancing the remedy to be utilized as an earlier remedy for persistent AF, which can result in higher long-term outcomes and set up the FARAPULSE PFA System as the popular methodology for treating the illness.”
Sufferers to Be Enrolled
The randomized AVANT GUARD trial will enroll greater than 500 sufferers recognized with persistent AF at as much as 75 websites globally. Sufferers within the research will probably be randomized to bear pulmonary vein isolation (PVI) and left atrial posterior wall ablation utilizing the FARAPULSE PFA System, or obtain AAD remedy, and adopted for 3 years. The trial will consider the outcomes of remedy supplied with the FARAPULSE PFA System versus AADs, together with device-or procedure-related opposed occasions, the charges of freedom from AF, atrial flutter, or atrial tachycardia, in addition to AF burden – a measurement of the quantity of AF a person experiences.
LUX-Dx™ Insertable Cardiac Monitor
All sufferers within the trial will even be inserted with the Boston Scientific LUX-Dx™ Insertable Cardiac Monitor. This gadget simplifies the monitoring course of for sufferers by mechanically capturing and transmitting arrhythmia episode information, and is designed to detect recurrence of cardiac arrhythmias and assess AF burden by offering steady rhythm monitoring.
This week, the Cleveland Clinic enrolled the primary affected person within the AVANT GUARD trial, overseen by Dr. Oussama Wazni, vice chair of cardiovascular drugs and part head, Cardiac Electrophysiology and Pacing, Cleveland Clinic, who can also be serving because the lead investigator of the trial.
FARAPULSE PFA System is Noninferior
Earlier this yr, medical trial information introduced demonstrated the FARAPULSE PFA System is noninferior to standard-of-care therapies for the remedy of paroxysmal AF, with superior effectivity, whereas extra real-world information from greater than 17,000 sufferers demonstrated continued real-world security, efficacy and effectivity of the system. Boston Scientific additionally accomplished enrollment within the first section of the ADVANTAGE AF medical trial within the third quarter of 2023, which is finding out the system for the remedy of sufferers with drug refractory symptomatic persistent AF, and commenced enrollment in an extension arm of the research to guage the protection and effectiveness of adjunctive use of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablations, a process used to deal with atrial flutter.
The corporate now anticipates U.S. Meals and Drug Administration approval of the FARAPULSE PFA System within the first quarter of 2024. Further details about medical proof supporting the gadget might be discovered here.
*Warning: Investigational Gadget. Restricted by Federal (or US) regulation to investigational use solely. Not out there on the market.