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NCT06808217Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
550 (actual)
First submitted
29 Jan 2025
Start date
30 Jul 2025
Primary completion date
1 Apr 2027
Lead sponsor
Boston Scientific Corporation
NCT number
NCT06808217

What you commit to

  • Study type: Observational
  • Participants enrolled: 550
  • From 30 Jul 2025 to the primary completion date, 1 Apr 2027
  • 22 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Allgemeines Krankenhaus AKH
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ViennaAustriaUnknown status
Cardiocentro Ticino
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LuganoSwitzerlandUnknown status
University Hospital Zurich
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ZurichSwitzerlandUnknown status
Vivantes Klinikum am Urban
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BerlinGermanyUnknown status
MVZ CCB Frankfurt und Main-Taunus GbR
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FrankfurtGermanyUnknown status
Asklepios Klinik Saint Georg
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HamburgGermanyUnknown status
Hospital De Basurto
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BilbaoSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
CHRU de Clermont-Ferrand
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Clermont-FerrandFranceUnknown status
Chu Grenoble
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GrenobleFranceUnknown status
Hospital Europeen Georges-Pompidou (HEGP)
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ParisFranceUnknown status
Hospital de la Pitié-Salpêtrière
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ParisFranceUnknown status
Centre Cardiologique du Nord
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Saint-DenisFranceUnknown status
Chu de Saint Etienne
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Saint-Priest-en-JarezFranceUnknown status
Clinique Pasteur
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ToulouseFranceUnknown status
Henry Dunant Hospital Center
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AthensGreeceUnknown status
Ippokrateio General Hospital
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ThessalonikiGreeceUnknown status
Mater Private Hospital
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DublinIrelandUnknown status
Clinica Montevergine
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MercoglianoItalyUnknown status
Centre Hospitalier Princesse Grace
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MonacoMonacoUnknown status
Erasmus MC University Medical Center
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RotterdamNetherlandsUnknown status
Isala Klinieken
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ZwolleNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.