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

Last updated: April 12, 2020
Sponsor: Trialance SCCL
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04344704
DX01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 462
Study Start date:
November 02, 2018
Estimated Completion Date:
March 31, 2023

Study 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

Connect with a study center

  • Hospital Universitario Clínico de Santiago

    Santiago De Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital Universitario de Araba

    Gasteiz / Vitoria, Alava 01009
    Spain

    Active - Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    Donostia, Guipúzcoa 20014
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra 36213
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Canarias

    Santa Cruz De Tenerife, Tenerife 38320
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Universitario Josep Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital San Pedro

    Logroño, 26006
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario de Tarragona Joan XXIII

    Tarragona, 43005
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Clínico y Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

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