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.
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
. 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
Exclusion criteria
. Subjects with a current interatrial baffle or patch
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 is labeled 'real world data collection' using the FARAPULSE Pulsed Field Ablation system — can you explain how pulsed field ablation differs from the heat- or cold-based ablation methods I might have heard about, and whether it might be relevant to my type of atrial fibrillation?
2Since this study is no longer enrolling new participants, does that mean the FARAPULSE system is already being used in clinical practice, and if so, is it something you'd consider for my care outside of a trial?
3The study is listed as 'Phase NA,' which suggests it's focused on collecting real-world effectiveness data rather than testing something new — does that mean more is already known about the safety profile of this device compared to an early-phase trial, and how does that affect how we should think about the risks?
4What does the 'primary effectiveness endpoint' they're measuring actually tell us about how well pulsed field ablation controls atrial fibrillation, and is there any early data from this study or similar ones we could look at together?
5Before considering any ablation approach, should we first discuss whether medication management or other non-invasive options might be a better starting point for my specific situation?
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.