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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Subjects who underwent prior AF ablation procedure.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines two procedures — pulsed field ablation for AF and left atrial appendage closure — at the same time, so could you walk me through why doing both together might be better or riskier for me compared to having them done separately or not at all?
2The trial is listed as Phase NA, which I understand means it's evaluating a device or combined procedure rather than a drug — what does that mean for how much safety data already exists on doing these two procedures together?
3The primary safety endpoint is tracking serious adverse events related to the device or procedure — what kinds of serious complications are they specifically watching for, and how does that risk compare to my current treatment options?
4Since one of the main things being measured is 'acute treatment success' right after the procedure, what would that actually mean for my day-to-day life longer term, and is there follow-up data beyond the initial result?
5Given that this trial is still actively recruiting, how would my care change if I joined — would I be giving up access to any standard treatments I might otherwise be offered right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events
. 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\*.
. 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.