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 range18 Years – 80 Years
SexALL
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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.
✕. 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
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
✕. 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