AVANT GUARD Clinical Trial

Striving to treat patients earlier

Why AVANT GUARD?

The AVANT GUARD trial aims to assess the safety and effectiveness of FARAPULSE™* Pulsed Field Ablation (PFA) as a first-line treatment for patients with persistent atrial fibrillation (PersAF) compared to initial treatment with anti-arrhythmic drugs (AADs).

FARAPULSE PFA is a novel ablation modality for treating atrial fibrillation (AF) using electrical pulses. This technique ablates the myocardium through electroporation of the cardiac cell membrane, avoiding tissue heating.
The FARAPULSE PFA catheter has been approved in the US, Canada, EU, Asia-Pacific, and Australia for treating paroxysmal AF (PAF).
Additional studies are required to obtain data on PersAF to expand the indication to a larger group of patients. AVANT GUARD is the first randomized, controlled trial comparing AAD therapy and PFA ablation as the first-line treatment for PersAF patients.
Participating in this study provides the possibility of treating patients earlier with FARAPULSE PFA.

Trial design and primary endpoints

AVANT GUARD is a prospective, randomized, multicenter, global, pivotal IDE study. Subjects with PersAF will be randomized 2:1 to either FARAPULSE PFA or AAD treatment. The primary safety endpoint is to demonstrate an acceptable safety profile of FARAPULSE PFA as an alternative to AADs and an initial rhythm control strategy. The primary effectiveness endpoint will compare rates of freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) between cohorts.

Prospective, Multi-Center, Global, Pivotal IDE with up to 75 Global Sites in US, Europe, Canada, and Asia Pacific.

Patients that are initially randomized to the AAD arm who fail AAD treatment are eligible for a FARAPULSE ablation after the 3-month blanking period. These patients will continue to be followed for up to 36 months.

Trial timeline

See below for an overview of both the FARAPULSE PFA and AAD group treatment timelines.

Other trial information

Both FARAPULSE PFA and AAD groups will use LUX-Dx^TM, an insertable cardiac monitor (ICM), to assess AF recurrence and AF burden through the 36-month follow-up. The insertion of the ICM, a small subcutaneous device, is low risk and will provide critical data on AF in both groups of the study.

The ICM technology ensures continuous rhythm monitoring and achieves higher patient compliance compared to traditional event monitors. The ICM collects AF burden and duration of asymptomatic episodes which are critical aspects linked to patient outcomes.

group of smiling people and doing jogging in the morning.

Patient Selection

AVANT GUARD seeks to demonstrate FARAPULSE PFA as a first-line treatment vs AADs for patients with persistent AF.

Review who may be eligible for the trial

* CAUTION: Investigational device. Limited by US law to investigational use only. Not available for sale.