REPRESENT-PF Registry

ConditionsPersistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorVivek Reddy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Racial or ethnic minorities defined based on 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

FARAWAVE Pulsed Field Ablation Catheter
Device
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.

Treatment groups

275 Participants

are divided into 1 treatment group

Group A: Patients indicated for atrial arrhythmia ablation1 intervention

Trial outcomes

Primary outcomes

Composite Serious Adverse Events

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.

Time frame

up to Day 60 Post Procedure

Chronic Treatment Success

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

Time frame

12 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vivek Reddy

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov

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