Clinical trial NCT06431828: Remote Symptom Review in Patients With Implantable Diagnostic Holter
Official title: Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Syncope
Bradycardia
Arrythmia
Keywords: Implantable loop recorder
Arrythmia
Atrial Fibrillation
Home Monitoring
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
Collaborators: name: Fundacin Biomedica Galicia Sur
name: Fundacion Investigacion Interhospitalaria Cardiovascular
First posted: 2024-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: TIME FRAME
timeFrame: one year
Secondary outcomes:
measure: Number of in-person visits in each group
timeFrame: one year
measure: Incidence remote transmissions activated by patient indication
timeFrame: one year
measure: Rate of false positives
timeFrame: one year
measure: Rate of symptoms sent by the patient
timeFrame: one year
measure: Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient
timeFrame: one year
measure: Rate of symptoms not corresponding to detected arrhythmias
timeFrame: one year
measure: Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.
timeFrame: one year
measure: Efficacy of implementing a clinical process based on remote monitoring of patient symptoms
timeFrame: one year
measure: Qualitative Patient Objectives
timeFrame: one year
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Servicio Galego de Saude
name: Andrés Iñiguez Romo, MD, phD
role: STUDY_CHAIR
References:
citation: 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.
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.
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 Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27.