Atrial FibrillationOPALISENCT06808217
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
An observational study of Atrial Fibrillation and Pulsed Field Ablation, run by Boston Scientific Corporation at 22 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Pulsed Field Ablation, FARAPULSE
- What is being tested?
- FARAPULSE Pulsed Field Ablation System
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 22 sitesin 10 countries
- Study dates
- 30 Jul 2025to 1 Apr 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: • Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
France7 sites
CHRU de Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble
Hospital de la Pitie-Salpetriere
Paris
Hospital Europeen Georges-Pompidou (HEGP)
Paris
Centre Cardiologique du Nord
Saint-Denis
CHU de Saint-Etienne
Saint-Priest-en-Jarez
Clinique Pasteur
Toulouse
Germany3 sites
Vivantes Klinikum Am Urban
Berlin
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt
Asklepios Klinik Saint Georg
Hamburg
Greece2 sites
Henry Dunant Hospital Center
Athens
Ippokrateio General Hospital
Thessaloniki
Netherlands2 sites
Erasmus MC- University Medical Center
Rotterdam
Isala Klinieken
Zwolle
Switzerland2 sites
Cardiocentro Ticino
Lugano
University Hospital Zurich
Zurich
About this study
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.
- Conditions
- Atrial Fibrillation, Pulsed Field Ablation, FARAPULSE
- Being tested
- FARAPULSE Pulsed Field Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FARAPULSE Pulsed Field Ablation SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The Primary Safety Endpoint is defined as the rate of device or procedure related serious adverse events following the index procedure through the 12 Month Follow-up
Measured: 12 months
Primary effectiveness Endpoint
The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start30 Jul 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808217
- Sponsor's protocol ID
- PF337
- Acronym
- OPALISE
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No