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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

NCT ID: NCT06808217

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-30

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Pulsed Field Ablation FARAPULSE

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allgemeines Krankenhaus AKH

Vienna, , Austria

Site Status NOT_YET_RECRUITING

Klinicki bolnicki centar Zagreb

Zagreb, , Croatia

Site Status NOT_YET_RECRUITING

CHRU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

CHU Grenoble

Grenoble, , France

Site Status RECRUITING

Hospital de la Pitie-Salpetriere

Paris, , France

Site Status NOT_YET_RECRUITING

Hospital Europeen Georges-Pompidou (HEGP)

Paris, , France

Site Status NOT_YET_RECRUITING

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status RECRUITING

CHU de Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

Vivantes Klinikum Am Urban

Berlin, , Germany

Site Status NOT_YET_RECRUITING

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, , Germany

Site Status RECRUITING

Asklepios Klinik Saint Georg

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Henry Dunant Hospital Center

Athens, , Greece

Site Status RECRUITING

Ippokrateio General Hospital

Thessaloniki, , Greece

Site Status NOT_YET_RECRUITING

Ippokrateio General Hospital

Thessaloniki, , Greece

Site Status NOT_YET_RECRUITING

Mater Private Hospital

Dublin, , Ireland

Site Status RECRUITING

Maria Cecilia Hospital

Cotignola, , Italy

Site Status NOT_YET_RECRUITING

Clinica Montevergine

Mercogliano, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Civile Di Piacenza

Piacenza, , Italy

Site Status NOT_YET_RECRUITING

Sheikh Jaber Al Ahmad Hospital

Kuwait City, , Kuwait

Site Status NOT_YET_RECRUITING

Centre Hospitalier Princesse Grace

Monaco, , Monaco

Site Status RECRUITING

Eramus MC- University Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

Isala Klinieken

Zwolle, , Netherlands

Site Status NOT_YET_RECRUITING

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Uniwersytecki Szpital Kliniczny Wrocławiu

Wroclaw, , Poland

Site Status NOT_YET_RECRUITING

National Guard Hospital

Riyadh, , Saudi Arabia

Site Status NOT_YET_RECRUITING

Hospital de Basurto

Bilbao, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status NOT_YET_RECRUITING

Cardiocentro Ticino

Lugano, , Switzerland

Site Status NOT_YET_RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status NOT_YET_RECRUITING

Cleveland Clinic London

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Austria Croatia France Germany Greece Ireland Italy Kuwait Monaco Netherlands Poland Saudi Arabia Spain Switzerland United Kingdom

Central Contacts

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Hanneke Rombouts

Role: CONTACT

Phone: 0032 480 69 00 65

Email: [email protected]

Facility Contacts

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Robert Schonbauer, MD

Role: primary

Vedran Velagic, MD

Role: primary

Gregoire Massoullie, MD

Role: primary

Pascal Defaye, PD

Role: primary

Mikael Laredo, MD

Role: primary

Eloi Marijon, MD

Role: primary

Antoine Lepillier, MD

Role: primary

Antoine Da Costa, MD

Role: primary

Serge Boveda, MD

Role: primary

Niels-Christian Ewertsen

Role: primary

Julian Chun, MD

Role: primary

Arian Sultan, MD

Role: primary

Georgios Andrikopoulos, MD

Role: primary

Fragakis, MD

Role: primary

Vasilikos, MD

Role: primary

Gabor Szeplaki, MD

Role: primary

Iacopino, MD

Role: primary

Solimene, MD

Role: primary

Luca Rossi, MD

Role: primary

Fawziah Al Kandari, MD

Role: primary

Decebal-Gabriel Latcu, MD

Role: primary

Sing-Chien Yap, MD

Role: primary

Ahmet Adiyaman, MD

Role: primary

Jakub Baran, MD

Role: primary

krzysztof Nowak, MD

Role: primary

Haitham Alanazi, MD

Role: primary

Jesus Daniel Martinez Alday, MD

Role: primary

Nicasio Perez Castellano, MD

Role: primary

Victor Exposito Garcia, MD

Role: primary

Giulio Conte, MD

Role: primary

Alexander Breitenstein, MD

Role: primary

Christopher A Rinaldi, MD

Role: primary

Other Identifiers

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PF337

Identifier Type: -

Identifier Source: org_study_id