Atrial Fibrillation (AF)OPTION-EMEANCT07349121
OPTION-EMEA Clinical Trial
A study testing Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case and Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure in people with Atrial Fibrillation (AF) and Stroke Prevention in Patients With Atrial Fibrillation, run by Boston Scientific Corporation at 5 sites in 5 countries.
Trial summary
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure
- What is being tested?
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case and Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 18 Jun 2026to Dec 2029
- Phase
- Interventional
- 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
Who may be able to join
- Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.
- Subjects who are willing and able to provide informed consent.
- Subjects who are willing and able to participate in all testing associated with this clinical study at an approved 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 who underwent prior AF ablation procedure.
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
- Already surgically closed or otherwise excluded LAA.
- The LAA anatomy does not accommodate a Closure Device.
- Known or suspected atrial myxoma.
- Presence of intracardiac thrombus*.
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- Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device.
- Subjects with a presence of a mechanical valve prosthesis in any position.
- Subjects with a myocardial infarction within 90 days prior to enrollment.
- Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.
- Any planned electrical cardioversion within 30 days following LAAC device implant.
- Subjects with a known inability to obtain vascular access.
- Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.
- Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).
- Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.
- Subjects who are pregnant or planning to be pregnant.
- 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 reviewed by the sponsor to determine eligibility.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Katherine A Beattie, Sr. Clinical Trial Manager, RN contact
5 sites in 5 countries
Belgium1 site, 1 recruiting
- Recruiting
AZORG - Hospital
Aalst
Thomas De Potter, MD
Thomas De Potter, MD
Croatia1 site, 1 recruiting
- Recruiting
Klinicki bolnicki centar Zagreb
Zagreb
Vedran Velagic, MD
Vedran Velagic, MD
France1 site, 1 recruiting
- Recruiting
Clinique Pasteur - Toulouse
Toulouse
Serge Boveda, MD
Serge Boveda, MD
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese
Carlo Pappone, MD
Carlo Pappone, MD
Spain1 site, 1 recruiting
- Not yet recruiting
University Hospital of Salamanca
Salamanca
Ignacio Cruz-Gonzalez
Ignacio Cruz-Gonzalez, MD
About this study
Official title: Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.
The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation, Atrial Fibrillation Ablation Procedure, Concomitant Procedures
- Being tested
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Keywords
- WATCHMAN, FARAPULSE, Concomitant, PFA, LAAC
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional caseDevice
left atrial appendage closure
Concomitant Pulsed Field Ablation and Left Atrial Appendage ClosureProcedure or surgery
FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | Subjects who meet eligibility criteria will undergo AF ablation and left atrial appendage closure using the FARAPULSE PFA system and WATCHMAN FLX Pro or WATCHMAN FLX during one interventional case. Receives: Device: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case; Procedure: Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure.
Measured: 30 days following the index procedure.
Primary Efficacy Endpoint (PEE): Acute Treatment Success
The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted.
Measured: Through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349121
- Sponsor's protocol ID
- S2605
- Acronym
- OPTION-EMEA
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]
- ClinicalTrials.gov ID
- NCT07349121
- Acronym / sponsor ID
- OPTION-EMEA / S2605
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation, Atrial Fibrillation Ablation Procedure, Concomitant Procedures
- Keywords
- WATCHMAN, FARAPULSE, Concomitant, PFA, LAAC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Jan 2026 (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 OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.
The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Device: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Procedure: Concomitant Pulsed Field Ablation and Left Atrial Appendage ClosureSubjects who meet eligibility criteria will undergo AF ablation and left atrial appendage closure using the FARAPULSE PFA system and WATCHMAN FLX Pro or WATCHMAN FLX during one interventional case. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.
- Subjects who are willing and able to provide informed consent.
- Subjects who are willing and able to participate in all testing associated with this clinical study at an approved 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 (18 listed)
- Subjects who underwent prior AF ablation procedure.
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
- Already surgically closed or otherwise excluded LAA.
- The LAA anatomy does not accommodate a Closure Device.
- Known or suspected atrial myxoma.
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 |
|---|---|---|
| Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional caseleft atrial appendage closure | Device | Single arm study |
| Concomitant Pulsed Field Ablation and Left Atrial Appendage ClosureFARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case. | Procedure or surgery | Single arm study |
Primary outcome
Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
Time frame: 30 days following the index procedure.
The PSE is the proportion of subjects who experience one or more device- or procedure-related composite serious adverse events (CSAEs) assessed at 30 days following the index procedure.
Primary Efficacy Endpoint (PEE): Acute Treatment Success
Time frame: Through 30 days
The PEE is the proportion of subjects with Acute Treatment Success assessed among those receiving ≥ 1 PFA application and who have WATCHMAN device deployment attempted or successfully implanted.
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 13 Oct 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.
Katherine A Beattie, Sr. Clinical Trial Manager, RN contact
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case and Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure in people with Atrial Fibrillation (AF) and Stroke Prevention in Patients With Atrial Fibrillation, run by Boston Scientific Corporation at 5 sites in 5 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 18 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Croatia, France, Italy, Spain. 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?
Contact Katherine A Beattie, Sr. Clinical Trial Manager, RN (+1 612 819 4540, Katherine.beattie@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events (time frame: 30 days following the index procedure.). The study lists 2 primary outcomes in all. 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 13 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.