Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452589
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-05
Brief Title:
The Field PULSE Study
Sponsor:
Field Medical
Organization:
Field Medical
Study Overview
Official Title:
A Pre-Market First-In-Human Pilot Interventional Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce Ablation System in Patients With Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Atrial fibrillation AF is a cardiac rhythm disorder characterized by irregular and often abnormally fast contractions of the atrial cardiomyocytes resulting in various symptoms including palpitations dizziness shortness of breath and tiredness
AF is the most common sustained cardiac arrhythmia having a prevalence of about 2 in the general population AF can be associated with increased morbidity and mortality in patients with cardiovascular disease and increased risk of stroke in general population
Catheter ablation for the treatment of AF is primarily performed with radiofrequency RF or cryoballoon CB catheters to achieve anatomic pulmonary vein isolation PVI However the technical challenges of achieving effective PVI and recognized risks of complications are two most important factors driving the need for replacing thermal ablation technologies like RF and CB
Pulsed field ablation PFA is a non-thermal ablation technology which uses high voltage pulsed electrical fields to ablate tissues This destabilizes cell membranes by forming irreversible nanoscale pores and leakage of cell contents culminating in cell death Several clinical studies have demonstrated that PFA can achieve pulmonary vein isolation with minimal collateral damage in a time-efficient manner
The FieldForce Ablation System utilizes PFA with an innovative electrode technology called FieldBending designed to improve safety tolerability and efficacy for focal deflectable catheters used for the treatment of AF
AF is the most common sustained cardiac arrhythmia having a prevalence of about 2 in the general population AF can be associated with increased morbidity and mortality in patients with cardiovascular disease and increased risk of stroke in general population
Catheter ablation for the treatment of AF is primarily performed with radiofrequency RF or cryoballoon CB catheters to achieve anatomic pulmonary vein isolation PVI However the technical challenges of achieving effective PVI and recognized risks of complications are two most important factors driving the need for replacing thermal ablation technologies like RF and CB
Pulsed field ablation PFA is a non-thermal ablation technology which uses high voltage pulsed electrical fields to ablate tissues This destabilizes cell membranes by forming irreversible nanoscale pores and leakage of cell contents culminating in cell death Several clinical studies have demonstrated that PFA can achieve pulmonary vein isolation with minimal collateral damage in a time-efficient manner
The FieldForce Ablation System utilizes PFA with an innovative electrode technology called FieldBending designed to improve safety tolerability and efficacy for focal deflectable catheters used for the treatment of AF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None