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
- Diseases
- Atrial fibrillation
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Allgemeines Krankenhaus AKH Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Cardiocentro Ticino Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Vivantes Klinikum am Urban Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| MVZ CCB Frankfurt und Main-Taunus GbR Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Asklepios Klinik Saint Georg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Hospital De Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| CHRU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hospital Europeen Georges-Pompidou (HEGP) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hospital de la Pitié-Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Ippokrateio General Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Mater Private Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Clinica Montevergine Coordinator of this site? Confirm its status | Mercogliano | Italy | Unknown status |
| Centre Hospitalier Princesse Grace Coordinator of this site? Confirm its status | Monaco | Monaco | Unknown status |
| Erasmus MC University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Isala Klinieken Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.