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)

October 21, 2026 updated by: Boston Scientific Corporation

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Erasmus 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 12 months

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
Time Frame: 12 Months

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

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 23, 2026

Last Update Submitted That Met QC Criteria

October 21, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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