Arrythmia, Atrial Fibrillation, Bradycardia, Syncope
Conditions
Keywords
Implantable loop recorder, Arrythmia, Atrial Fibrillation, Home Monitoring
Brief summary
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.
Detailed description
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.
Interventions
OTHERAPP
The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.
Sponsors
Fundacin Biomedica Galicia Sur
Fundacion Investigacion Interhospitalaria Cardiovascular
Andres Iñiguez Romo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection) * Patients over 18 years old. * Patients who consent to the installation of a patient application for telematic submission of patient-related symptoms. * Patients capable of using the patient application.
Exclusion criteria
* Patients over 80 years of age or, failing that, not able to use an application to send their symptoms. * Life expectancy of less than 12 months for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIME FRAME | one year | Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence remote transmissions activated by patient indication | one year | Number of remote transmissions activated by patient indication |
| Rate of false positives | one year | Number of false positives, according to physician's diagnosis. |
| Rate of symptoms sent by the patient | one year | Number of false positives (according to physician's diagnosis) |
| Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient | one year | 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) |
| Number of in-person visits in each group | one year | Number of in-person visits in each group |
| Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient. | one year | Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.corresponds to a detected arrhythmia |
| Efficacy of implementing a clinical process based on remote monitoring of patient symptoms | one year | Change in patient interaction with the physician - fewer calls/visits to the hospital. |
| Qualitative Patient Objectives | one year | Measured through a satisfaction survey on the use or non-use of the patient application to telematically send their symptoms |
| Rate of symptoms not corresponding to detected arrhythmias | one year | Rate of symptoms not corresponding to detected arrhythmias(e.g., the symptom corresponds to a detected arrhythmia) |
Countries
Spain
Contacts
Primary ContactAndrés Iñiguez Romo, MD, PhD
Backup ContactElvis Teijeira Fernández, MD, PhD
Outcome results
None listed