Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Conditions
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
Interventions
OTHERSingle chamber DAI device with floating atrial dipole
DAI for the detection of atrial signals with optimized programming, using Smart, Onset & Stability, and Morphmatch methods
Sponsors
Trialance SCCL
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Programming adjustment justification | 24 months | Adjustments suggested by the European Heart Rhythm Association |
| Distribution of inappropriate therapies by chosen schedule | 24 months | — |
| Proportion of appropriate and inappropriate diagnoses | 24 months | By diagnosis group |
| Differences in events according to Onset & Stability method versus Morphmatch method | 24 months | Events in single chamber programming without floating dipole |
| Appropriate therapies by group and by indication | 24 months | Portion of appropriate therapies |
| Inappropriate therapies distribution | 24 months | According to the type of indication for an ICD in primary and secondary prevention |
| Patients presenting atrial fibrillation before inclusion | 24 months | percentage |
| Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up | 24 months | Percentage |
| 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). | 24 months | Clinical AF meaning \> 6 minutes duration and subclinical AF meaning \<6 minutes duration |
| Cerebrovascular events presenting previous episodes of atrial fibrillation | 24 months | Rate |
| Triggers of Inappropriate therapies | 24 months | — |
Countries
Spain
Contacts
Primary ContactXavier Molina Figueras, PharmD, PhD
Backup ContactMarta Barbacid Hernández, PharmD, MSc
Outcome results
None listed