To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.
Population of patients: Patients over 18 years old who require the implantation of an implantable diagnostic holter due to indications of syncope or atrial fibrillation, and who are willing to use an application installed on their phone to telematically send clinical symptoms that may occur during the active study period. Design: Clinical, randomized, prospective, single-center study. Investigational Device: BIOMONITOR III implantable cardiac holter and successive models with HOMEMONITORING remote monitoring system for constant monitoring of patient's cardiac signals. Installation of the Patient APP on the patient's phone for symptom transmission. Overall Objective: To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.
Hospital Álvaro Cunqueiro
Vigo, Spain
RECRUITINGTIME FRAME
Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication.
Time frame: one year
Number of in-person visits in each group
Number of in-person visits in each group
Time frame: one year
Incidence remote transmissions activated by patient indication
Number of remote transmissions activated by patient indication
Time frame: one year
Rate of false positives
Number of false positives, according to physician's diagnosis.
Time frame: one year
Rate of symptoms sent by the patient
Number of false positives (according to physician's diagnosis)
Time frame: one year
Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient
Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient (e.g., the symptom corresponds to a detected arrhythmia)
Time frame: one year
Rate of symptoms not corresponding to detected arrhythmias
Rate of symptoms not corresponding to detected arrhythmias(e.g., the symptom corresponds to a detected arrhythmia)
Time frame: one year
Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.
Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.corresponds to a detected arrhythmia
Time frame: one year
Efficacy of implementing a clinical process based on remote monitoring of patient symptoms
Change in patient interaction with the physician - fewer calls/visits to the hospital.
Time frame: one year
Qualitative Patient Objectives
Measured through a satisfaction survey on the use or non-use of the patient application to telematically send their symptoms
Time frame: one year
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