Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Pulsed Field Ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFARAWAVE 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-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year) This device is FDA approved.
Sponsors
Vivek Reddy
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Serious Adverse Events | up to Day 60 Post Procedure | Assess device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure The proportion of all Treatment Subjects and Attempt Subjects (combined PAF and PersAF cohort) with one or more device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure on or prior to the Day 60 Assessment, with an Onset Date following the procedure. |
| Chronic Treatment Success | 12 Months | Chronic treatment success is defined as freedom from any of the following through the Day 365: * Arrhythmia: Occurrence of any detectable AF, AFL or AT * Re-ablation: Any re-ablation for AF, AFL or AT at any time following the index procedure after the blanking period. * Cardioversion: Any electrical cardioversion for AF, AFL or AT |
Countries
United States
Contacts
CONTACTDevin Chamberlain
CONTACTBetsy Ellsworth, MSN, ANP
PRINCIPAL_INVESTIGATORVivek Reddy, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed