Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
- Conditions
- Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
- Interventions
- Other: Single chamber DAI device with floating atrial dipole
- Registration Number
- NCT04344704
- Lead Sponsor
- Trialance SCCL
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 462
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DX device programmed in single chamber mode Single chamber DAI device with floating atrial dipole 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 DX devices with SMART headset detection enabled Single chamber DAI device with floating atrial dipole 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Inappropriate therapies distribution 24 months According to the type of indication for an ICD in primary and secondary prevention
Programming adjustment justification 24 months Adjustments suggested by the European Heart Rhythm Association
Appropriate therapies by group and by indication 24 months Portion of appropriate therapies
Proportion of appropriate and inappropriate diagnoses 24 months By diagnosis group
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
Distribution of inappropriate therapies by chosen schedule 24 months Differences in events according to Onset & Stability method versus Morphmatch method 24 months Events in single chamber programming without floating dipole
Triggers of Inappropriate therapies 24 months 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 Cerebrovascular events presenting previous episodes of atrial fibrillation 24 months Rate
Trial Locations
- Locations (16)
Hospital Universitario Josep Trueta
🇪🇸Girona, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario de Araba
🇪🇸Gasteiz / Vitoria, Alava, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, Guipúzcoa, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario de Tarragona Joan XXIII
🇪🇸Tarragona, Spain
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Universitario de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Clínico de Santiago
🇪🇸Santiago De Compostela, A Coruña, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Complejo Hospitalario Universitario de Canarias
🇪🇸Santa Cruz De Tenerife, Tenerife, Spain
Hospital Clínico y Universitario de Valladolid
🇪🇸Valladolid, Spain