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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

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

Intervention / Treatment
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* Other: Single chamber DAI device with floating atrial dipole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DX devices with SMART headset detection enabled<br>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 | Other: Single chamber DAI device with floating atrial dipole<br>* DAI for the detection of atrial signals with optimized programming, using Smart, Onset & Stability, and Morphmatch methods<br>|
| DX device programmed in single chamber mode<br>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 | Other: Single chamber DAI device with floating atrial dipole<br>* DAI for the detection of atrial signals with optimized programming, using Smart, Onset & Stability, and Morphmatch methods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The combined rate of inappropriate therapies and serious adverse cardiac and cerebrovascular events (MACCE) single-chamber devices with floating atrial dipole with the Smart function activated | determine the combined rate is not less than in single-chamber devices without atrial detection using any of the supraventricular arrhythmia discrimination modalities: Onset and Stability, and Morphmatch. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate therapies distribution | According to the type of indication for an ICD in primary and secondary prevention | 24 months | 
| Programming adjustment justification | Adjustments suggested by the European Heart Rhythm Association | 24 months | 
| Distribution of inappropriate therapies by chosen schedule |  | 24 months | 
| Proportion of appropriate and inappropriate diagnoses | By diagnosis group | 24 months | 
| Differences in events according to Onset & Stability method versus Morphmatch method | Events in single chamber programming without floating dipole | 24 months | 
| Appropriate therapies by group and by indication | Portion of appropriate therapies | 24 months | 
| Triggers of Inappropriate therapies |  | 24 months | 
| Patients presenting atrial fibrillation before inclusion | percentage | 24 months | 
| Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up | Percentage | 24 months | 
| General atrial load in patients with and without previous manifestation of atrial fibrillation |  | 24 months | 
| Percentage of patients with clinical AF (atrial fibrillation) versus subclinical AF (<6 minutes duration). | Clinical AF meaning > 6 minutes duration and subclinical AF meaning <6 minutes duration | 24 months | 
| Cerebrovascular events presenting previous episodes of atrial fibrillation | Rate | 24 months |