Clinical trial NCT04344704: Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Lead sponsor: Trialance SCCL
Sponsor class: INDUSTRY
First posted: 2020-04-14
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population with an accepted indication for an implantable automatic defibrillator

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 24 months
Secondary outcomes:
measure: Inappropriate therapies distribution
timeFrame: 24 months
measure: Programming adjustment justification
timeFrame: 24 months
measure: Distribution of inappropriate therapies by chosen schedule
timeFrame: 24 months
measure: Proportion of appropriate and inappropriate diagnoses
timeFrame: 24 months
measure: Differences in events according to Onset & Stability method versus Morphmatch method
timeFrame: 24 months
measure: Appropriate therapies by group and by indication
timeFrame: 24 months
measure: Triggers of Inappropriate therapies
timeFrame: 24 months
measure: Patients presenting atrial fibrillation before inclusion
timeFrame: 24 months
measure: Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up
timeFrame: 24 months
measure: General atrial load in patients with and without previous manifestation of atrial fibrillation
timeFrame: 24 months
measure: Percentage of patients with clinical AF (atrial fibrillation) versus subclinical AF (<6 minutes duration).
timeFrame: 24 months
measure: Cerebrovascular events presenting previous episodes of atrial fibrillation
timeFrame: 24 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario Clínico de Santiago
state: A Coruña
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario de Araba
state: Alava
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Guipúzcoa
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: Santa Cruz De Tenerife
country: Spain
facility: Complejo Hospitalario Universitario de Canarias
state: Tenerife
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Girona
country: Spain
facility: Hospital Universitario Josep Trueta
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Tarragona
country: Spain
facility: Hospital Universitario de Tarragona Joan XXIII
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico y Universitario de Valladolid
Study officials:
affiliation: Hospital Universitario Puerta de Hierro (HUPH)
name: Ignacio Fernández Lozano, MD
role: PRINCIPAL_INVESTIGATOR
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