A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation (OPALISE)

The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation; Pulsed Field Ablation; FARAPULSE
• Intervention / Treatment: Device: FARAPULSE Pulsed Field Ablation System

• Study Type: Observational
• Enrollment (Actual): 550

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Allgemeines Krankenhaus AKH
• France
  • Clermont-Ferrand, France
    • CHRU de Clermont-Ferrand
  • Grenoble, France
    • CHU Grenoble
  • Paris, France
    • Hospital de la Pitie-Salpetriere
  • Paris, France
    • Hospital Europeen Georges-Pompidou (HEGP)
  • Saint-Denis, France
    • Centre Cardiologique du Nord
  • Saint-Priest-en-Jarez, France
    • Chu de Saint-Etienne
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Berlin, Germany
    • Vivantes Klinikum Am Urban
  • Frankfurt, Germany
    • MVZ CCB Frankfurt und Main-Taunus GbR
  • Hamburg, Germany
    • Asklepios Klinik Saint Georg
• Greece
  • Athens, Greece
    • Henry Dunant Hospital Center
  • Thessaloniki, Greece
    • Ippokrateio General Hospital
• Ireland
  • Dublin, Ireland
    • Mater Private Hospital
• Italy
  • Mercogliano, Italy
    • Clinica Montevergine
• Monaco
  • Monaco, Monaco
    • Centre Hospitalier Princesse Grace
• Netherlands
  • Rotterdam, Netherlands
    • Eramus MC- University Medical Center
  • Zwolle, Netherlands
    • Isala Klinieken
• Spain
  • Bilbao, Spain
    • Hospital de Basurto
  • Madrid, Spain
    • Hospital Clinico San Carlos
• Switzerland
  • Lugano, Switzerland
    • Cardiocentro Ticino
  • Zurich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.

Description

Inclusion Criteria:

• Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
• Subjects who are willing and capable of providing informed consent
• Subjects who are willing and capable of participating to this Registry at an approved clinical investigational center
• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
• Subjects are planned to undergo an ablation procedure whereby the FARAWAVE NAV PF Ablation Catheter is used in conjunction with the OPAL HDx Mapping System.

Exclusion Criteria:

• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	The Primary Safety Endpoint is defined as the rate of device or procedure related serious adverse events following the index procedure through the 12 Month Follow-up	12 months
Primary effectiveness Endpoint	The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success	12 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PF337

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No