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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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.

Locations (20)

Allgemeines Krankenhaus AKH
Vienna, Austria
Klinicki bolnicki centar Zagreb
Zagreb, Croatia
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
Ippokrateio General Hospital
Thessaloniki, Greece
Mater Private Hospital
Dublin, Ireland
Maria Cecilia Hospital
Cotignola, Italy
Clinica Montevergine
Mercogliano, Italy
Ospedale Civile Di Piacenza
Piacenza, Italy
Sheikh Jaber Al Ahmad Hospital
Kuwait City, Kuwait