The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.
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:
* Subject must provide written informed consent prior to any clinical investigation-related procedure.
* 18 years of age or older, or the age of legal consent
* CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
* Able to stop anticoagulation by 90 days post index procedure
* Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT
* Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF
* Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
Paroxysmal:
* Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND
* One electrocardiographically documented PAF episode within 12 months prior to enrollment.
Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
* Physician's note, AND either
* 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR
* Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
* That are taken at least 7 days apart but less than 12 months apart
* If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
* The most recent electrocardiogram must be within 180 days of enrollment.
NOTE: Documented evidenc…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
LAA occlusion success determined by peri-device flow ≤5mm
Timeframe: From treatment through 3-month follow-up vists
2
Occurrence of specific adverse events between time of implant and 7 days post-procedure or hospital discharge, whichever was later
Timeframe: From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is later