The Field PULSE Study
NCT06452589 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-05-14
Summary
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation.
Conditions
- Atrial Arrhythmias
Interventions
- DEVICE
-
FieldForce Ablation System
The FieldForce Ablation System is indicated for cardiac electrophysiologic mapping, delivery of diagnostic pacing stimuli, and pulse field ablation of cardiac tissue. When used with the FieldForce Ablation Catheter, the FieldForce System is intended to be used in the right/left atria and/or left/right ventricle to deliver PFA ablation lesions in the selected areas of the chamber.
Sponsors & Collaborators
-
Field Medical
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
- 2024-07-25
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- Czechia
Study Locations
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