MedTrace Logo

The FARAPULSE FARA-Freedom Trial

NCT05072964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-10-17

Study results available
· View outcomes & findings →

Summary

The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

FARAPULSE Pulsed Field Ablation System

A pulmonary vein isolation will be performed using catheter ablation

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2023-10-12
Completion
2023-10-19
FDA Device
Yes

Countries

  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

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 NCT05072964 on ClinicalTrials.gov