Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection (PREVENT-DX)

Trialance

Status: Unknown

Conditions: Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD

Treatments: Other: Single chamber DAI device with floating atrial dipole

Study type: Observational

Funder types: Industry

Identifiers

NCT04344704

DX01

Details and patient eligibility

About

Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection

Full 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

Enrollment: 462 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with an indication of a single chamber ICD due to high risk of sudden death.
• Patients with and without a prior history of AF.
• Patients with indication for primary and secondary prevention.
• Device optimized for the discrimination of supraventricular events.
• DX device implant with single floating cable.
• Activation of "Home Monitoring" function.
• Over 18 years.
• Signature of informed consent

Exclusion criteria

• Indication for permanent atrial pacing according to current pacing guidelines.
• Congestive heart failure grade IV.
• Candidates for Cardiac Resynchronization Therapy.
• Patients with a previous device.
• Permanent Atrial Fibrillation.
• Life expectancy less than 12 months.
• Pregnant or lactating women.
• Patients who are unable to understand the nature of the study.
• Subjects with irreversible brain damage caused by pre-existing brain disease.
• Heart transplant 6 months prior to recruitment or expected in the next 3 months.
• Cardiac surgery 3 months prior to recruitment or planned for the next 3 months.

Trial design

462 participants in 2 patient groups

DX devices with SMART headset detection enabled

Description:

The SMART detection algorithm is designed to, with the aid of atrial rhythm assessment, discriminate between ventricular tachycardias and a variety of supraventricular tachyarrhythmias for which device intervention is not required or desired

Treatment:

Other: Single chamber DAI device with floating atrial dipole

DX device programmed in single chamber mode

Description:

with the activation of one of the available discrimination criteria: * Onset: distinguishes slow onset or onset tachycardias from sudden onset * Stability: distinguishes between irregularly transmitted supraventricular tachycardias and ventricular tachycardias requiring therapy by continuous interval monitoring. * Morphmatch: helps to distinguish between supra and ventricular signals through analysis of episode QRS width

Treatment:

Other: Single chamber DAI device with floating atrial dipole