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

April 12, 2020 updated by: Trialance SCCL

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

462

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enrique Ricoy Martínez, Cardiologist
        • Sub-Investigator:
          • Ignacio Mosquera Pérez, Cardiologist
        • Sub-Investigator:
          • Luisa Pérez Álvarez, Cardiologist
        • Sub-Investigator:
          • Jorge Rodríguez Garrido, Cardiologist
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitario Josep Trueta
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilce Trucco, Cardiologist
      • Logroño, Spain, 26006
        • Recruiting
        • Hospital San Pedro
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Manuel Forcada Sainz, Cardiologist
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Luís Merino Llorens, Cardiologist
        • Sub-Investigator:
          • Omar Al Razo Hameed, Cardiologist
        • Sub-Investigator:
          • Sergio Castrejón Castrejón, Cardiologist
        • Sub-Investigator:
          • Elkin González Villegas, Cardiologst
      • Málaga, Spain, 29010
        • Active, not recruiting
        • Hospital Universitario Virgen De La Victoria
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitario de Tarragona Joan XXIII
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramón de Castro, Cardiologist
        • Sub-Investigator:
          • Sandra Cabrera, Cardiologist
        • Sub-Investigator:
          • Gabriel Martín, Cardiologist
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politecnico La Fe
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joaquin Osca Asensi, Cardiologist
        • Sub-Investigator:
          • María José Sancho-Tello de Carranza, Cardiologist
        • Sub-Investigator:
          • Oscar Cano Pérez, Cardiologist
        • Sub-Investigator:
          • Asunción Saurí Ortiz, Cardiologist
        • Sub-Investigator:
          • Mª Teresa izquierdo de Francisco, Cardiologist
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico y Universitario de Valladolid
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Elpidio García Granja, Cardiologist
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Active, not recruiting
        • Hospital Universitario Clínico de Santiago
    • Alava
      • Gasteiz / Vitoria, Alava, Spain, 01009
        • Recruiting
        • Hospital Universitario de Araba
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jon Ortuño Aguado, Cardiologist
        • Sub-Investigator:
          • María Robledo, Cardiologist
        • Sub-Investigator:
          • Enrique García Cuenca, Cardiologist
        • Sub-Investigator:
          • Irene Juanes Domínguez, Cardiologist
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roger Villuendas Sabaté, Cardiologist
        • Sub-Investigator:
          • Victor Bazán, Cardiologist
        • Sub-Investigator:
          • Asier Molinero, Cardiologist
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignasi Anguera Camos, Cardiologist
    • Guipúzcoa
      • Donostia, Guipúzcoa, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Manuel Porres Aracama, Intensivist
        • Sub-Investigator:
          • Francisco García Urra, Intensivist
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta De Hierro
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignacio Fernández Lozano, Cardiologist
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Recruiting
        • Hospital Álvaro Cunqueiro
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elvis Teijeira Fernández, Cardiologist
        • Sub-Investigator:
          • Enrique García Campo, Cardiologist
        • Sub-Investigator:
          • Mónica Prado Fresno, Cardiologist
        • Sub-Investigator:
          • Pilar Cabañas Grandío, Cardiologist
        • Sub-Investigator:
          • Alejandro Silveira Correa, Cardiologist
    • Tenerife
      • Santa Cruz De Tenerife, Tenerife, Spain, 38320
        • Active, not recruiting
        • Complejo Hospitalario Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Population with an accepted indication for an implantable automatic defibrillator

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DX devices with SMART headset detection enabled
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
DAI for the detection of atrial signals with optimized programming, using Smart, Onset & Stability, and Morphmatch methods
DX device programmed in single chamber mode

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
DAI for the detection of atrial signals with optimized programming, using Smart, Onset & Stability, and Morphmatch methods

What is the study measuring?

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
Time Frame: 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.
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trialance SCCL

Investigators

  • Principal Investigator: Ignacio Fernández Lozano, MD, Hospital Universitario Puerta de Hierro (HUPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2018

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 12, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DX01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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