Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD Clinical Trial
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
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
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
;