Atrial FibrillationFARADISENCT05501873
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
An observational study of Atrial Fibrillation, run by Boston Scientific Corporation at 48 sites in 21 countries.
Trial summary
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FARAPULSE Pulsed Field Ablation system
- Type of treatment
- Medical device
- How many people
- 1,173 participants
- Where
- 48 sitesin 21 countries
- Study dates
- 24 Mar 2023to 15 Aug 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to the hospitals' standard of care
Who may be able to join
- Subjects 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 in all testing associated with this clinical study 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
Who cannot join
- Subjects with a current interatrial baffle or patch
- Subjects with a known or suspected atrial myxoma
- Subjects with a myocardial infarction within 14 days prior to enrollment
- Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
- Subjects who do not tolerate anticoagulation therapy
- Subjects with an active systemic infection *
Show all 14Show fewer
- Subjects with a presence of atrial known thrombus *
- Subjects with a known inability to obtain vascular access
- Subjects who are pregnant or planning to be pregnant
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
- Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure/unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
- Subjects with a life expectancy of ≤ 1 year per investigator's opinion
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility
Trial locations and contacts
48 sites in 21 countries.
48 sites in 21 countries
Germany7 sites
Universitaetsklinikum Aachen (UKA)
Aachen
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
Dresden
Georg-August-Universitaet Goettingen
Göttingen
St Georg Asklepios
Hamburg
Universitaetsklinikum Heidelberg
Heidelberg
Staedisches Klinikum Karlsruhe
Karlsruhe
University Hospital of Muenster
Münster
France6 sites
CHU Grenoble
Grenoble
Hopital Saint Philibert-Hospital
Lomme
Hopital Prive du Confluent SAS
Nantes
Clinique Ambroise Pare-Hospital
Neuilly
Centre Cardiologique du Nord
Saint-Denis
Clinique Pasteur Toulouse
Toulouse
Italy5 sites
Az. Osp. Lancisi-Hospital
Ancona
Casa Di Cura 'Montevergine' S.P.A.
Mercogliano
Ospedale Rivoli
Rivoli
Ospedale Isola Tiberina Gemelli Isola
Roma
Ospedale San Bortolo de Vicenza
Vicenza
Spain4 sites
Centro Especial Ramon y Cajal
Madrid
Clinica Universidad de Navarra
Pamplona
Hospital Universitario La Fe
Valencia
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Australia3 sites
Prince Charles Hospital
Brisbane
Fiona Stanley Hospital
Murdoch
John Hunter Hospital
Newcastle
Belgium3 sites
AZ Sint Jan Hospital
Bruges
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt
CHR de la Citadelle
Liège
Czechia2 sites
Neuron Medical in Brno
Brno
Nemocnice Ceske Budejovice a.s.
České Budějovice
Greece2 sites
Henry Dunant hospital
Athens
Onassis Cardiac Surgery Center
Athens
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven
St. Antonius Ziekenhuis
Nieuwegein
United Kingdom2 sites
Royal Papworth Hospital
Cambridge
Liverpool Heart & Chest Hospital
Liverpool
Poland1 site
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw
About this study
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.
Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death.
This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.
Read the detailed description
This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific).
- Conditions
- Atrial Fibrillation
- 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
Any subject who has signed the informed consent and for whom the FARAPULSE Pulsed Field Ablation system has been inserted into the body, and pulsed field ablation treatment has been received, are assigned to the treatment group.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Failure-free rate at 12 months post index procedure
Measured: 12 monhts
Secondary outcomes (1)
Safety endpoint
Composite of device- or procedure-related serious adverse events at early onset or chronic onset
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 posted16 Aug 2022
- Study start24 Mar 2023
- Primary completion21 Oct 2025
- Study completion15 Aug 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
- 1,173 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501873
- Sponsor's protocol ID
- PF114
- Acronym
- FARADISE
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
- ClinicalTrials.gov ID
- NCT05501873
- Acronym / sponsor ID
- FARADISE / PF114
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,173 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.
Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death.
This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.
Detailed description
This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to the hospitals' standard of care
Key inclusion criteria (4 listed)
- Subjects 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 in all testing associated with this clinical study 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
Key exclusion criteria (14 listed)
- Subjects with a current interatrial baffle or patch
- Subjects with a known or suspected atrial myxoma
- Subjects with a myocardial infarction within 14 days prior to enrollment
- Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
- Subjects who do not tolerate anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FARAPULSE Pulsed Field Ablation systemAny subject who has signed the informed consent and for whom the FARAPULSE Pulsed Field Ablation system has been inserted into the body, and pulsed field ablation treatment has been received, are assigned to the treatment group. | Device | – |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 12 monhts
Failure-free rate at 12 months post index procedure
1 secondary outcome
Safety endpoint
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Boston Scientific Corporation at 48 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Germany, France, Italy, Spain, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 12 monhts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.