Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
NCT ID: NCT04344704
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
462 participants
OBSERVATIONAL
2018-11-02
2023-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Trialance SCCL
INDUSTRY
Responsible Party
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Principal Investigators
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Ignacio Fernández Lozano, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro (HUPH)
Locations
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Hospital Universitario Clínico de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Alava, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipúzcoa, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Complejo Hospitalario Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitario Josep Trueta
Girona, , Spain
Hospital San Pedro
Logroño, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario de Tarragona Joan XXIII
Tarragona, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Clínico y Universitario de Valladolid
Valladolid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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DX01
Identifier Type: -
Identifier Source: org_study_id
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