Remote monitoring of heart symptoms using a smartphone app
Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.
This study tests if using a smartphone app to monitor heart symptoms can help people with heart conditions like atrial fibrillation feel better compared to regular hospital check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundacin Biomedica Galicia Sur Academic / other |
| Locations | 1 site (Vigo) |
| Trial ID | NCT06431828 on ClinicalTrials.gov |
What this trial studies
This study evaluates the benefits of using a remote monitoring system for patients with implantable diagnostic holters, specifically the BIOMONITOR III. Patients will use a smartphone application to report symptoms and receive alerts from the device, allowing for continuous monitoring of their heart conditions. The effectiveness of this remote monitoring approach will be compared to traditional hospital monitoring methods. The study aims to improve patient management and outcomes for those with conditions like atrial fibrillation and syncope.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who require an implantable holter for monitoring atrial fibrillation or syncope and are willing to use a smartphone app.
Not a fit: Patients over 80 years old or those unable to use the application may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of heart conditions and improved patient outcomes through timely interventions.
How similar studies have performed: Other studies have shown promise in remote monitoring for similar heart conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vigo
- Hospital Álvaro Cunqueiro — Vigo, Spain (Recruiting)
Study contacts
- Study coordinator: Andrés Iñiguez Romo, MD, PhD
- Email: andres.iniguez.romo@sergas.es
- Phone: +34986825564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.