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

NCT06808217 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2025-07-30

Last updated

2026-09-24

Condition(s) studied

Atrial FibrillationPulsed Field AblationFARAPULSE

Investigational drug(s) / intervention(s)

FARAPULSE Pulsed Field Ablation System

FARAPULSE Pulsed Field Ablation System: Subjects who have provided written informed consent are considered enrolled. Subjects who have received ablation treatment with the FARAPULSE™ System are assigned to the 'TREATMENT' group.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Primary Safety Endpoint — 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
Primary effectiveness Endpoint — 12 Months
The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success

Trial sites (22)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808217 on ClinicalTrials.gov ↗ ← All trials in the Netherlands