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Clinical Trials in France / NCT06808217
Active, not recruiting Observational

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 France 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
No
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)

FacilityCityRegionStatus
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

More Boston Scientific Corporation trials in France

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism Active, not recruiting
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature Recruiting
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Active, not recruiting
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting

Other trials for the same condition

The Fourth Left Atrial Appendage Occlusion Study Recruiting
Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery Recruiting
Biological Bank for Atrial Fibrillation and Stroke Recruiting
AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE Recruiting
Avoiding Anticoagulation After IntraCerebral Haemorrhage Recruiting
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 France