Atrial FibrillationBIOMONI-DIGNCT06431828
Remote Symptom Review in Patients With Implantable Diagnostic Holter
A study testing APP in people with Atrial Fibrillation and Syncope, run by Andres Iñiguez Romo at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Syncope, Bradycardia
- What is being tested?
- APP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, 36211
Pablo Juan Salvadores, MPH,PhD, +34986825564, pablo.juan@iisgaliciasur.es
About this study
Official title: Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.
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.
Read the 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
- Atrial Fibrillation, Syncope, Bradycardia, Arrythmia
- Being tested
- APP
- Keywords
- Implantable loop recorder, Arrythmia, Atrial Fibrillation, Home Monitoring
- Medical subject headings
- Atrial Fibrillation, Syncope, Bradycardia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPOther
The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.
| Study group | Role | What they receive |
|---|---|---|
| Homemonitoring + APP | Experimental | The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events. Receives: Other: APP |
| Homemonitoring | No intervention | The patients receive the usual standard treatment with remote holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (9)
Number of in-person visits in each group
Number of in-person visits in each group
Measured: one year
Incidence remote transmissions activated by patient indication
Number of remote transmissions activated by patient indication
Measured: one year
Rate of false positives
Number of false positives, according to physician's diagnosis.
Measured: one year
Rate of symptoms sent by the patient
Number of false positives (according to physician's diagnosis)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start22 Apr 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andres Iñiguez Romo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacin Biomedica Galicia Sur, Fundacion Investigacion Interhospitalaria Cardiovascular
- Responsible party
- Sponsor-investigator, Andres Iñiguez Romo, Fundacin Biomedica Galicia Sur
- Investigators
- Andrés Iñiguez Romo, MD, phD, Study chair, Servicio Galego de Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431828
- Sponsor's protocol ID
- FF088
- Acronym
- BIOMONI-DIG
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34953575Sharma 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.
PubMed 34330370Varma 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.
PubMed 26661687
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.
- ClinicalTrials.gov ID
- NCT06431828
- Acronym / sponsor ID
- BIOMONI-DIG / FF088
- Conditions
- Atrial Fibrillation, Syncope, Bradycardia, Arrythmia
- Keywords
- Implantable loop recorder, Arrythmia, Atrial Fibrillation, Home Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andres Iñiguez RomoUniversity, hospital or other
- Collaborators
- Fundacin Biomedica Galicia Sur, Fundacion Investigacion Interhospitalaria Cardiovascular
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homemonitoring + APP | Experimental | Other: APPThe 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APPThe patients will download an app through which they will be able to report adverse events related to their cardiovascular health. | Other | Homemonitoring + APP |
Primary outcome
TIME FRAME
Time frame: one year
Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication.
9 secondary outcomes
Number of in-person visits in each group
Time frame: one year
Incidence remote transmissions activated by patient indication
Time frame: one year
Rate of false positives
Time frame: one year
Rate of symptoms sent by the patient
Time frame: one year
Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient
Time frame: one year
Rate of symptoms not corresponding to detected arrhythmias
Time frame: one year
Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.
Time frame: one year
Efficacy of implementing a clinical process based on remote monitoring of patient symptoms
Time frame: one year
Qualitative Patient Objectives
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Results publication: PubMed 34953575Gupta 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.
- Results publication: PubMed 34330370Sharma 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.
- Results publication: PubMed 26661687Varma 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrés Iñiguez Romo, MD, phD study chair
Servicio Galego de Saude
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP in people with Atrial Fibrillation and Syncope, run by Andres Iñiguez Romo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrés Iñiguez Romo, MD, PhD (+34986825564, andres.iniguez.romo@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIME FRAME (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06431828, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.