Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-29 @ 10:47 AM
Study NCT ID:
NCT04344704
Status:
UNKNOWN
Last Update Posted:
2020-04-14
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
Sponsor:
Trialance SCCL
Organization:
Study Overview
Official Title:
Prevention of Inappropriate Therapies and Serious Adverse Cardiac and Cerebrovascular Events With a Single Chamber Implantable Cardioverter Defibrillator (ICD) With DX Floating Dipole Detection. PREVENT DX
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
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:
PREVENT-DX
Brief Summary:
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
Detailed Description:
Prospective, randomized, open-label, multicenter, international study in a population with an accepted indication for an implantable automatic defibrillator.
The main objective is to know the different values of the rates of inappropriate therapies, of serious cardiac and cerebrovascular adverse events, and of the appropriate detections in single-chamber ICD devices, with optimized programming according to the patient's arrhythmic history, using the three discrimination methods. arrhythmias: Smart, Onset and Stability, and Morphmatch.
The device under investigation is a single chamber with a floating atrial dipole for the detection of atrial signals.
Patients who are included in the study will present an indication for an automatic cardioverter-defibrillator device according to clinical practice guidelines for an ICD and who also do not have an indication for permanent stimulation in the right atrium. For this reason, the indication of patients will be those that require an ICD without the implantation of an electrode in the atrium, that is, single-chamber ICDs or DX ICDs since both, from the therapeutic point of view, are equivalent.
The centers will follow standard clinical practice to diagnose patients
The main objective is to know the different values of the rates of inappropriate therapies, of serious cardiac and cerebrovascular adverse events, and of the appropriate detections in single-chamber ICD devices, with optimized programming according to the patient's arrhythmic history, using the three discrimination methods. arrhythmias: Smart, Onset and Stability, and Morphmatch.
The device under investigation is a single chamber with a floating atrial dipole for the detection of atrial signals.
Patients who are included in the study will present an indication for an automatic cardioverter-defibrillator device according to clinical practice guidelines for an ICD and who also do not have an indication for permanent stimulation in the right atrium. For this reason, the indication of patients will be those that require an ICD without the implantation of an electrode in the atrium, that is, single-chamber ICDs or DX ICDs since both, from the therapeutic point of view, are equivalent.
The centers will follow standard clinical practice to diagnose patients
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: