Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
NCT07575828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2026-05-08
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.
Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Persistent Atrial Fibrillation
Interventions
- DEVICE
-
PulseSelect Pulse Field Ablation (PFA) System
Adult subjects with recurrent symptomatic paroxysmal AF or persistent AF will be enrolled and undergo ablation with the PulseSelect™ PFA system.
Sponsors & Collaborators
-
Medtronic Cardiac Ablation Solutions
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-08-31
- Completion
- 2029-03-31
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