REPRESENT-PF Registry

Overview

This pragmatic, prospective, single-arm, multi-center, observational registry will evaluate the safety and effectiveness of PFA for the treatment of atrial fibrillation in underrepresented minority patients using FDA approved Boston Scientific PFA catheters; all data collected will be standard of care.

Catheter ablation is an established treatment for atrial fibrillation (AF) and is increasingly being utilized as first line therapy in patients with symptomatic AF. Pulsed field ablation (PFA) is a novel transformative technology that has demonstrated an excellent safety profile owing to its ability to achieve preferential myocardial tissue ablation and improve workflow efficiencies while exhibiting at least comparable efficacy to conventional thermal ablation modalities. This development has significant public health implications given the increasing prevalence of AF with associated morbidity and mortality. Historically, Blacks, Hispanics, Asians and other racial and ethnic minorities have been underrepresented in clinical trials on the management of AF and specifically catheter ablation. This is further compounded by the fact that racial and ethnic minorities experience higher rates of AF-related adverse events as compared to non-minorities while being significantly less likely to receive catheter ablation therapy. A multitude of factors have been identified as potential contributors to both the reduced utilization of catheter ablation therapy for under-represented minorities, and the increased event rates. The significant paucity of data limits more in depth analysis. It is therefore evident that greater strides towards inclusivity are needed to expand upon the clinical evidence with hopes of improving care delivery to this population. REPRESENT-PF is a pragmatic, prospective single-arm, multi-center, observational registry studying the safety and effectiveness of PFA in underrepresented minority patients indicated for atrial arrhythmia ablation performed with Boston Scientific FDA approved catheters. The study will include both paroxysmal and persistent patients with a 1- year follow up period. Racial or ethnic minorities will be defined based on a modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Central Contacts