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Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

NCT06765356 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2026-04-14

No results posted yet for this study

Summary

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Conditions

  • Persistent Atrial Fibrillation
  • Paroxysmal Atrial Fibrillation
  • Long-standing Persistent Atrial Fibrillation

Interventions

DEVICE

Farapulse Catheter System

The FARAWAVE PFA Catheter is a sterile, single use, over-the-wire, non-deflectable device that is used with the FARASTAR Catheter Connection Cable and FARASTAR Generator to enable delivery of Pulsed Field Ablation energy for irreversible electroporation. The FARAWAVE PFA Catheter has five (5) variably deployable splines. The five splines are undeployed during insertion and removal and during use can deploy continuously from an undeployed state through a partially deployed ("basket-shaped") configuration to a fully deployed ("flower-shaped") configuration with five petals.

DRUG

Low-dose Colchicine

For participants in the colchicine sub-study, 0.3 mg BID Colchicine. Colchicine will be prescribed to the patient starting 5 days prior to ablation. Patient will continue the colchicine for 3 weeks post-ablation.

Sponsors & Collaborators

  • Vivek Reddy

    lead OTHER

  • Boston Scientific Corporation

    collaborator INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · The Mount Sinai Hospital, Icahn School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2027-03-30
Completion
2027-03-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765356 on ClinicalTrials.gov