An interventional study of APP in Atrial Fibrillation, Syncope and Bradycardia, sponsored by Andres Iñiguez Romo. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Andres Iñiguez Romo · Not applicable, Interventional, and Diagnostic
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Andres Iñiguez Romo is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients receive the usual standard treatment with remote holter monitoring along with an app for the notification of adverse events.
Other: APP
The patients receive the usual standard treatment with remote holter monitoring
The patients will download an app through which they will be able to report adverse events related to their cardiovascular health.
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.
Time frame: one year
Number of in-person visits in each group
Number of in-person visits in each group
Time frame: one year
Incidence remote transmissions activated by patient indication
Number of remote transmissions activated by patient indication
Time frame: one year
Rate of false positives
Number of false positives, according to physician's diagnosis.
Time frame: one year
Rate of symptoms sent by the patient
Number of false positives (according to physician's diagnosis)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: one year
Plan to share: No
Started Apr 2024 (actual). Primary completion is estimated for May 2025, 13 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 13 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Andres Iñiguez Romo