RecruitingNCT06808217

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

Sponsor

Boston Scientific Corporation

Enrollment

500 participants

Start Date

Jul 30, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Pulsed Field Ablation FARAPULSE

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry is collecting real-world data on a heart procedure called pulsed field ablation, which uses electrical pulses to treat an irregular heartbeat called atrial fibrillation. The study tracks how a specific mapping system (OPAL HDx) and ablation catheter (FARAWAVE NAV) perform together. **You may be eligible if...** - You are 18 years or older - Your doctor has recommended pulsed field ablation to treat your irregular heartbeat - You are scheduled to have the procedure using the specific FARAWAVE NAV catheter and OPAL HDx mapping system - You are willing to participate and provide informed consent **You may NOT be eligible if...** - You are currently enrolled in another clinical study that would conflict with this one (purely observational registries are generally fine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFARAPULSE 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(32)

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

Centre Hospitalier Princesse Grace

Monaco, Monaco

Eramus MC- University Medical Center

Rotterdam, Netherlands

Isala Klinieken

Zwolle, Netherlands

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland

Uniwersytecki Szpital Kliniczny Wrocławiu

Wroclaw, Poland

National Guard Hospital

Riyadh, Saudi Arabia

Hospital de Basurto

Bilbao, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Cardiocentro Ticino

Lugano, Switzerland

University Hospital Zurich

Zurich, Switzerland

Cleveland Clinic London

London, United Kingdom

View Full Details on ClinicalTrials.gov

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