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A patient’s eligibility will be evaluated by the study’s enrolling physician. The main inclusion and exclusion criteria are below. Study patients need to meet all eligibility criteria. Please refer to the CT.gov website for a full list of criteria.
Age ≥ 18 years of age, or older if specified by local law
Have symptomatic persistent atrial fibrillation (AF), confirmed by both A & B:
A. Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either:
I. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR
II. Two ECGs (from regulatory cleared rhythm monitoring device) with continuous AF taken at least 7 days apart
B. Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days
Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx ICM that was inserted ≤ 6 months of consent
Over the 6 months preceding enrollment, more than a 7-day history of therapeutic AAD use (Class I or III), or ≥ 24 hours amiodarone, except for pill-in-the-pocket AAD use, which is permitted. Or, treated with AAD > 6 months preceding enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes).
Contraindication to, or unwillingness to use, systemic anticoagulation, AADs (Class I and III, excluding amiodarone which is not allowed during the study), and pulsed field ablation (PFA) treatment.
May require an ablation, besides the PV and PW, in the left atrium including, but not limited to, those with Left-Sided Atrioventricular Reentrant Tachycardia (AVRT), Left-Sided Atrial Tachycardia (AT), or Atypical Left-Sided Atrial Flutter.
AVANT GUARD aims to enroll diverse patients concerning gender, race, and ethnicity. Data shows the need to enroll and treat underrepresented populations¹. Given the increased AF risk factors and differences in management and treatment techniques among the underrepresented ethnic and racial groups, it is imperative to start improving the representation of these groups in catheter ablation trials. The study aims to enroll a minimum of 12-15% persons of color and 43-45% women globally.
References
AVANT GUARD is studying use of the FARAPULSE system in patients with persistent AF which is outside the current labeled indications. This is an investigational study.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries.
This material not intended for use in France.
