## Protocol Section
### Identification Module
**NCT ID:** NCT06431828

**Acronym:** BIOMONI-DIG

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** FF088
#### Organization
**Class:** OTHER
**Full Name:** Fundacin Biomedica Galicia Sur
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fundacin Biomedica Galicia Sur

**Class:** OTHER

**Name:** Fundacion Investigacion Interhospitalaria Cardiovascular

#### Lead Sponsor

**Class:** OTHER

**Name:** Andres Iñiguez Romo

#### Responsible Party

**Investigator Affiliation:** Fundacin Biomedica Galicia Sur

**Investigator Full Name:** Andres Iñiguez Romo

**Investigator Title:** Head of Cardiology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Atrial Fibrillation

- Syncope

- Bradycardia

- Arrythmia

**Keywords:**

- Implantable loop recorder

- Arrythmia

- Atrial Fibrillation

- Home Monitoring

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: APP

**Label:** Homemonitoring + APP

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The patients receive the usual standard treatment with remote holter monitoring

**Label:** Homemonitoring

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Homemonitoring + APP

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

**Name:** APP

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** TIME FRAME

**Time Frame:** one year

#### Secondary Outcomes

**Description:** Number of in-person visits in each group

**Measure:** Number of in-person visits in each group

**Time Frame:** one year

**Description:** Number of remote transmissions activated by patient indication

**Measure:** Incidence remote transmissions activated by patient indication

**Time Frame:** one year

**Description:** Number of false positives, according to physician's diagnosis.

**Measure:** Rate of false positives

**Time Frame:** one year

**Description:** Number of false positives (according to physician's diagnosis)

**Measure:** Rate of symptoms sent by the patient

**Time Frame:** one year

**Description:** 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)

**Measure:** Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient

**Time Frame:** one year

**Description:** Rate of symptoms not corresponding to detected arrhythmias(e.g., the symptom corresponds to a detected arrhythmia)

**Measure:** Rate of symptoms not corresponding to detected arrhythmias

**Time Frame:** one year

**Description:** Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.corresponds to a detected arrhythmia

**Measure:** Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.

**Time Frame:** one year

**Description:** Change in patient interaction with the physician - fewer calls/visits to the hospital.

**Measure:** Efficacy of implementing a clinical process based on remote monitoring of patient symptoms

**Time Frame:** one year

**Description:** Measured through a satisfaction survey on the use or non-use of the patient application to telematically send their symptoms

**Measure:** Qualitative Patient Objectives

**Time Frame:** one year

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** andres.iniguez.romo@sergas.es

**Name:** Andrés Iñiguez Romo, MD, PhD

**Phone:** +34986825564

**Role:** CONTACT

**Contact 2:**

**Email:** elvis.teijeira.fernandez@sergas.es

**Name:** Elvis Teijeira Fernández, MD, PhD

**Phone:** +34986825564

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vigo

**Contacts:**

***Contact 1:***

- **Email:** pablo.juan@iisgaliciasur.es

- **Name:** Pablo Juan Salvadores, MPH,PhD

- **Phone:** +34986825564

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Álvaro Cunqueiro

**Status:** RECRUITING

**Zip:** 36211

#### Overall Officials

**Official 1:**

**Affiliation:** Servicio Galego de Saude

**Name:** Andrés Iñiguez Romo, MD, phD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 34953575

**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.

**PMID:** 34330370

**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.

**PMID:** 26661687

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014474

- Term: Unconsciousness

- ID: D000003244

- Term: Consciousness Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M16353

- Name: Syncope

- Relevance: HIGH

- As Found: Syncope

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: HIGH

- As Found: Arrhythmia

- ID: M5196

- Name: Bradycardia

- Relevance: HIGH

- As Found: Bradycardia

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17224

- Name: Unconsciousness

- Relevance: LOW

- As Found: Unknown

- ID: M6468

- Name: Consciousness Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013575

- Term: Syncope

- ID: D000001281

- Term: Atrial Fibrillation

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000001919

- Term: Bradycardia

### Misc Info Module

- Version Holder: 2024-05-31
