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| Name | Class |
|---|---|
| Fundacin Biomedica Galicia Sur | OTHER |
| Fundacion Investigacion Interhospitalaria Cardiovascular | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homemonitoring + APP | Experimental | The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events. |
|
| Homemonitoring | No Intervention | The patients receive the usual standard treatment with remote holter monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APP | Other | The patients will download an app through which they will be able to report adverse events related to their cardiovascular health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of in-person visits in each group | Number of in-person visits in each group | one year |
| Incidence remote transmissions activated by patient indication | Number of remote transmissions activated by patient indication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrés Iñiguez Romo, MD, PhD | Contact | +34986825564 | andres.iniguez.romo@sergas.es | |
| Elvis Teijeira Fernández, MD, PhD | Contact | +34986825564 | elvis.teijeira.fernandez@sergas.es |
| Name | Affiliation | Role |
|---|---|---|
| Andrés Iñiguez Romo, MD, phD | Servicio Galego de Saude | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Álvaro Cunqueiro | Recruiting | Vigo | 36211 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34953575 | Result | 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. | |
| 34330370 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| D001919 | Bradycardia |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| one year |
| Rate of false positives | Number of false positives, according to physician's diagnosis. | one year |
| Rate of symptoms sent by the patient | Number of false positives (according to physician's diagnosis) | one year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 26661687 | 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. |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |