Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203262
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-12-30
Brief Title:
Ventricular Catheter Ablation Study VCAS
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 Symptomatic Patients With Ventricular Arrhythmia
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:
VCAS
Brief Summary:
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce Ablation system in patients with ventricular arrhythmia divided into two groups VT VCAS-I and frequent premature ventricular complex VCAS-II
Detailed Description:
Summary
Ventricular arrythmias are common but often undertreated The most effective pharmacologic management and implantable devices are used to treat deadly arrythmias like ventricular tachycardia VT and ventricular fibrillation VF However the efficacy of antiarrhythmic drugs AADs has been proven to be low and implantable cardioverter defibrillators ICDs treat VT but do not prevent it Prospective trials demonstrate that VT ablation is by far the most effective therapy for ventricular tachycardia and in some cases it is curative Despite overwhelming evidence that catheter ablation is superior there are many technical barriers that prevent widespread application of this therapy Furthermore non-fatal ventricular arrythmias such as premature ventricular contractions PVCs are treatable by catheter ablation The technical challenges facing VT and PVC ablations are similar as current technologies are optimized to treat atrial arrythmias often at the expense of performance in the ventricle
Pulsed field ablation PFA is a new ablation method for the therapy of arrhythmias PFA is considered as a non-thermal and low-energy method of ablation This technique is characterized by pulse trains of short-duration and high-voltage electrical impulses that result in electric field-mediated tissue injury The very strong electric fields put strain on cellular compartmentalization These changes can be reversible and cells can recover with no consequences however if compartmentalization is disrupted for an extended period of time it results in metabolic injury and cell death This mechanism is also known as electroporation Different cell types are sensitive to these types of insults leading to tissue selectivity in the heart Clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation However there is less data on the application of PFA for VT
Therefore this Pre-Market First-In-Human Pilot Interventional Clinical Investigation aims to evaluate Safety and Feasibility of the FieldForce Ablation system in patients with ventricular tachycardia divided into two groups ventricular tachycardia VCAS-I and unifocal premature ventricular complex VCAS-II
Ventricular arrythmias are common but often undertreated The most effective pharmacologic management and implantable devices are used to treat deadly arrythmias like ventricular tachycardia VT and ventricular fibrillation VF However the efficacy of antiarrhythmic drugs AADs has been proven to be low and implantable cardioverter defibrillators ICDs treat VT but do not prevent it Prospective trials demonstrate that VT ablation is by far the most effective therapy for ventricular tachycardia and in some cases it is curative Despite overwhelming evidence that catheter ablation is superior there are many technical barriers that prevent widespread application of this therapy Furthermore non-fatal ventricular arrythmias such as premature ventricular contractions PVCs are treatable by catheter ablation The technical challenges facing VT and PVC ablations are similar as current technologies are optimized to treat atrial arrythmias often at the expense of performance in the ventricle
Pulsed field ablation PFA is a new ablation method for the therapy of arrhythmias PFA is considered as a non-thermal and low-energy method of ablation This technique is characterized by pulse trains of short-duration and high-voltage electrical impulses that result in electric field-mediated tissue injury The very strong electric fields put strain on cellular compartmentalization These changes can be reversible and cells can recover with no consequences however if compartmentalization is disrupted for an extended period of time it results in metabolic injury and cell death This mechanism is also known as electroporation Different cell types are sensitive to these types of insults leading to tissue selectivity in the heart Clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation However there is less data on the application of PFA for VT
Therefore this Pre-Market First-In-Human Pilot Interventional Clinical Investigation aims to evaluate Safety and Feasibility of the FieldForce Ablation system in patients with ventricular tachycardia divided into two groups ventricular tachycardia VCAS-I and unifocal premature ventricular complex VCAS-II
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