Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Álvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Andrés Iñiguez Romo, MD, PhD
andres.iniguez.romo@sergas.es
+34986825564
Backup
Elvis Teijeira Fernández, MD, PhD
elvis.teijeira.fernandez@sergas.es
+34986825564
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2026-05
Participants
Target number of participants: 60
Treatments
Experimental: Homemonitoring + APP
The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events.
No_intervention: Homemonitoring
The patients receive the usual standard treatment with remote holter monitoring
Related Therapeutic Areas
Sponsors
Collaborators: Fundacin Biomedica Galicia Sur, Fundacion Investigacion Interhospitalaria Cardiovascular
Leads: Andres Iñiguez Romo

This content was sourced from clinicaltrials.gov