Sam Brusco, Associate Editor01.02.24
Boston Scientific began the AVANT GUARD clinical trial to evaluate safety and effectiveness of its Farapulse pulsed field ablation (PFA) system as a first-line treatment for persistent atrial fibrillation (AF).
Farapulse is a nonthermal treatment where electric fields selectively ablate heart tissue. Outcomes of ablation using Farapulse will be compared to those following use of anti-arrhythmic drug (AAD) therapy.
The company said AVANT GUARD is the only trial to study PFA’s use as frontline therapy in patients 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 trial will enroll over 500 patients, who will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using Farapulse, or receive AAD therapy, and followed for three years. The trial will evaluate outcomes of therapy provided with Farapulse 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.
All patients in the trial will also be inserted with the Boston Scientific LUX-Dx insertable cardiac monitor (ICM), the company said. Boston Scientific now anticipates U.S. Food and Drug Administration (FDA) approval of Farapulse in Q1 2024.
Farapulse is a nonthermal treatment where electric fields selectively ablate heart tissue. Outcomes of ablation using Farapulse will be compared to those following use of anti-arrhythmic drug (AAD) therapy.
The company said AVANT GUARD is the only trial to study PFA’s use as frontline therapy in patients 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 trial will enroll over 500 patients, who will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using Farapulse, or receive AAD therapy, and followed for three years. The trial will evaluate outcomes of therapy provided with Farapulse 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.
All patients in the trial will also be inserted with the Boston Scientific LUX-Dx insertable cardiac monitor (ICM), the company said. Boston Scientific now anticipates U.S. Food and Drug Administration (FDA) approval of Farapulse in Q1 2024.