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

NCT04344704 | Unknown

• 1 other identifier: DX01
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 16

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

Conditions

Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (12)

• Inappropriate therapies distribution

  24 months

• Programming adjustment justification

  24 months

• Distribution of inappropriate therapies by chosen schedule

  24 months

• Proportion of appropriate and inappropriate diagnoses

  24 months

• Differences in events according to Onset & Stability method versus Morphmatch method

  24 months

Study Arms (2)

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

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

Interventions

Single chamber DAI device with floating atrial dipole OTHER

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

DX device programmed in single chamber mode; DX devices with SMART headset detection enabled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population with an accepted indication for an implantable automatic defibrillator

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trialance SCCL: lead

Study Sites (16)

Hospital Universitario Clínico de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Araba

Vitoria-Gasteiz, Alava, 01009, Spain

RECRUITING

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

RECRUITING

Complejo Hospitalario Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, 38320, Spain

ACTIVE NOT RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Universitario Josep Trueta

Girona, 17007, Spain

RECRUITING

Hospital San Pedro

Logroño, 26006, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Tarragona Joan XXIII

Tarragona, 43005, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Clínico y Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (25)

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Study Officials

• Ignacio Fernández Lozano, MD

  Hospital Universitario Puerta de Hierro (HUPH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Molina Figueras, PharmD, PhD

CONTACT

+34 689900009; xmolina@trialance.com

Marta Barbacid Hernández, PharmD, MSc

CONTACT

+34 630767668; mbarbacid@trialance.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 14, 2020
• Study Start: November 2, 2018
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

ES (16)