Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543173
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
Primary Preventive Ventricular Tachycardia Ablation in High-Risk Patients Who Receive a Prophylactic Implantable Cardioverter Defibrillator
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Primary Preventive Ventricular Tachycardia Ablation in High-Risk Patients Who Receive a Prophylactic Implantable Cardioverter Defibrillator PRIMARY PREVENT-VT TRIAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENT-VT
Brief Summary:
This prospective multicenter open-label randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy ICM patients referred for primary ICD implantation Participants will be randomized to receive either prophylactic VT ablation within three months of ICD implantation or continued medical management The primary objective is to assess the efficacy of preventive VT ablation versus medical management in reducing VT arrhythmia burden
Detailed Description:
This study aims to assess the impact of prophylactic catheter-based ventricular tachycardia VT ablation compared to medical management in high-risk patients with ischemic cardiomyopathy ICM undergoing primary implantable cardioverter defibrillator ICD implantation The primary outcome measure is the burden of VT arrhythmias VTA defined as the total number of VT events one year post-ICD implantation The hypothesis suggests that employing VT ablation with high-density electroanatomic mapping EnsiteTM will significantly reduce both treated and monitored VT episodes The study will randomize 62 participants in a 11 ratio across 20 experienced sites in Europe
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None