Remote Symptom Review in Patients With Implantable Diagnostic Holter

Last updated: May 30, 2024
Sponsor: Andres Iñiguez Romo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Dizzy/fainting Spells

Arrhythmia

Treatment

APP

Clinical Study ID

NCT06431828
FF088
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients indicated for implantation of a subcutaneous implantable holter due tosyncope or cryptogenic stroke (atrial fibrillation detection)

  • Patients over 18 years old.

  • Patients who consent to the installation of a patient application for telematicsubmission of patient-related symptoms.

  • Patients capable of using the patient application.

Exclusion

Exclusion Criteria:

  • Patients over 80 years of age or, failing that, not able to use an application tosend their symptoms.

  • Life expectancy of less than 12 months for any reason.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: APP
Phase:
Study Start date:
April 22, 2024
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Hospital Álvaro Cunqueiro

    Vigo, 36211
    Spain

    Active - Recruiting

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