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A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation

NCT05443594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2025-12-16

Study results available
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Summary

The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Phase 1: FARAPULSE Ablation System

PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.

DEVICE

Phase 2: FARAPULSE Ablation System

PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy · MOUNT SINAI HOSPITAL

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-02-11
Completion
2025-02-11
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Spain

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 NCT05443594 on ClinicalTrials.gov