REPRESENT-PF Registry

Официальное название

Prospective Multicenter Registry on the Clinical Outcomes and Safety of PFA for Atrial Fibrillation in Underrepresented Minorities (REPRESENT-PF Registry)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство FARAWAVE Pulsed Field Ablation Catheter
  The FARAWAVE Pulsed Field Ablation (PFA) Catheter is a component of the FARAPULSE PFA System. The FARAWAVE Catheter is an over-the-wire, multi-electrode catheter designed to deliver PFA energy to the distal section for cardiac ablation. The FARAWAVE Catheter is indicated for: 1) the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) 2) the isolation of pulmonary veins and the posterior wall in the treatment of drug-refrac

Первичные конечные точки

• Composite Serious Adverse Events [Срок оценки: up to Day 60 Post Procedure]
• Chronic Treatment Success [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• All consecutive patients classified as racial or ethnic minorities undergoing ablation using Boston Scientific FDA approved PFA catheters for AF will be included.
• De novo ablation for symptomatic paroxysmal and persistent AF (Age ≥ 18) (unless it is a repeat for a patient whose index procedure is also in the registry) who are deemed to be candidates for AF ablation by the investigator.
• Able and willing to participate in baseline and follow up evaluation over the study period
• Willing and able to provide informed consent, if applicable.

Критерии исключения

• Enrolled in an investigational drug or device clinical trial or any other trial with outlined treatment plan
• Long standing persistent AF (AF > 1 year duration)
• Repeat ablation, unless index ablation procedure was in the REPRESENT-PF registry
• Any known contra-indication to ablation procedure at the discretion of the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 2 центра

• The Mount Sinai Hospital — New York
• Valley Health System — Winchester

Идентификаторы

NCT: NCT07535268 · STUDY-25-01408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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