Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06431828

Remote Symptom Review in Patients With Implantable Diagnostic Holter

Led by Andres Iñiguez Romo · Updated on 2024-05-31

60

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

Sponsors

A

Andres Iñiguez Romo

Lead Sponsor

F

Fundacin Biomedica Galicia Sur

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Remote Symptom Review in Patients With Implantable Diagnostic Holter

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients over 80 years of age or unable to use an application to send their symptoms
  • Life expectancy of less than 12 months for any reason

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Álvaro Cunqueiro

Vigo, Spain, 36211

Actively Recruiting

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Research Team

A

Andrés Iñiguez Romo, MD, PhD

CONTACT

E

Elvis Teijeira Fernández, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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