Remote Symptom Review in Patients With Implantable Diagnostic Holter

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06431828
Study type	Interventional
Source	Fundacin Biomedica Galicia Sur
Contact	Andrés Iñiguez Romo, MD, PhD
Phone	+34986825564
Email	andres.iniguez.romo@sergas.es
Status	Recruiting
Phase	N/A
Start date	April 22, 2024
Completion date	May 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Remote Symptom Review in Patients With Implantable Diagnostic Holter — BIOMONI-DIG

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms