Remote Symptom Review in Patients With Implantable Diagnostic Holter

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation Syncope Bradycardia Arrythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Homemonitoring + APP

The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events.

Group Type EXPERIMENTAL

APP

Intervention Type OTHER

The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.

Homemonitoring

The patients receive the usual standard treatment with remote holter monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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APP

The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No