Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysm… (NCT07575828) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
320 participantsStarted 2026-08
Plain-language summary
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.
Who can participate
Age range
18 Years – 80 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
. Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
. Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 12 months prior to enrollment; AND
. at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
. Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 12 months prior to enrollment; AND
. any 24-hour continuous ECG recording documenting continuous AF within 12 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 12 months prior to enrollment
. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Exclusion criteria
. Long-standing persistent AF (continuous AF that is sustained \>12 months)
. Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.
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
Safety: Number of Participants with at Least One Primary Safety Event
Timeframe: Up to 6 months post procedure
2
Effectiveness: Number of Participants with Treatment Success
. Paroxysmal AF: LA anteroposterior diameter \> 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter \> 5.5 cm (by MRI, CT, or TTE)
. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
. Contraindication to or unwillingness to use systemic anticoagulation