Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431828
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-08
Brief Title:
Remote Symptom Review in Patients With Implantable Diagnostic Holter
Sponsor:
Andres Iñiguez Romo
Organization:
Fundacin Biomedica Galicia Sur
Study Overview
Official Title:
Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOMONI-DIG
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 patients 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 patients cardiac signals Installation of the Patient APP on the patients 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 patients phone The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital
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 patients cardiac signals Installation of the Patient APP on the patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None