Remote Symptom Review in Patients With Implantable Diagnostic Holter

NCT06431828 | Recruiting

• 1 other identifier: FF088
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Syncope; Bradycardia; Arrythmia

Keywords

Implantable loop recorder; Arrythmia; Atrial Fibrillation; Home Monitoring

Outcome Measures

Primary Outcomes (1)

• TIME FRAME

  Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication.

  one year

Secondary Outcomes (9)

• Number of in-person visits in each group

  one year

• Incidence remote transmissions activated by patient indication

  one year

• Rate of false positives

  one year

• Rate of symptoms sent by the patient

  one year

• Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient

  one year

Study Arms (2)

Homemonitoring + APP

EXPERIMENTAL

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

Other: APP

Homemonitoring

NO INTERVENTION

The patients receive the usual standard treatment with remote holter monitoring

Interventions

APP OTHER

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

Homemonitoring + APP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andres Iñiguez Romo: lead
• Fundacin Biomedica Galicia Sur: collaborator
• Fundacion Investigacion Interhospitalaria Cardiovascular: collaborator

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, 36211, Spain

RECRUITING

Related Publications (3)

• Gupta N, Yang J, Reynolds K, Lenane J, Garcia E, Sung SH, Harrison TN, Solomon MD, Go AS; KP-RHYTHM Study Group. Diagnostic Yield, Outcomes, and Resource Utilization With Different Ambulatory Electrocardiographic Monitoring Strategies. Am J Cardiol. 2022 Mar 1;166:38-44. doi: 10.1016/j.amjcard.2021.11.027. Epub 2021 Dec 23.

  PMID: 34953575 RESULT

• Sharma AN, Baranchuk A. Ambulatory External Electrocardiography Monitoring: Holter, Extended Holter, Mobile Cardiac Telemetry Monitoring. Card Electrophysiol Clin. 2021 Sep;13(3):427-438. doi: 10.1016/j.ccep.2021.04.003. Epub 2021 Jul 8.

  PMID: 34330370 RESULT

• Varma N, Epstein AE, Schweikert R, Michalski J, Love CJ; TRUST Investigators. Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial. J Cardiovasc Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27.

  PMID: 26661687 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Syncope; Bradycardia; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Andrés Iñiguez Romo, MD, phD

  Servicio Galego de Saude

  STUDY CHAIR

Central Study Contacts

Andrés Iñiguez Romo, MD, PhD

CONTACT

+34986825564; andres.iniguez.romo@sergas.es

Elvis Teijeira Fernández, MD, PhD

CONTACT

+34986825564; elvis.teijeira.fernandez@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 29, 2024
• Study Start: April 22, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)