Remote Symptom Review in Patients With Implantable Diagnostic Holter

Atrial Fibrillation Clinical Trial

— BIOMONI-DIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431828
• Other study ID #: FF088
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Fundacin Biomedica Galicia Sur
• Contact: Andrés Iñiguez Romo, MD, PhD
• Phone: +34986825564
• Email: andres.iniguez.romo[@]sergas.es
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Atrial Fibrillation
• Bradycardia
• Syncope

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (3)

Lead Sponsor	Collaborator
Andres Iñiguez Romo	Fundacin Biomedica Galicia Sur, Fundacion Investigacion Interhospitalaria Cardiovascular

Country where clinical trial is conducted

Spain, 

References & 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 — View Citation

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. — View Citation

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 Electrophys — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of in-person visits in each group	Number of in-person visits in each group	one year
Secondary	Incidence remote transmissions activated by patient indication	Number of remote transmissions activated by patient indication	one year
Secondary	Rate of false positives	Number of false positives, according to physician's diagnosis.	one year
Secondary	Rate of symptoms sent by the patient	Number of false positives (according to physician's diagnosis)	one year
Secondary	Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient	Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient (e.g., the symptom corresponds to a detected arrhythmia)	one year
Secondary	Rate of symptoms not corresponding to detected arrhythmias	Rate of symptoms not corresponding to detected arrhythmias(e.g., the symptom corresponds to a detected arrhythmia)	one year
Secondary	Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.	Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.corresponds to a detected arrhythmia	one year
Secondary	Efficacy of implementing a clinical process based on remote monitoring of patient symptoms	Change in patient interaction with the physician - fewer calls/visits to the hospital.	one year
Secondary	Qualitative Patient Objectives	Measured through a satisfaction survey on the use or non-use of the patient application to telematically send their symptoms	one year