Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312501
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-06
Brief Title:
Remote Patient Monitoring for Patients With Heart Failure in France
Sponsor:
Satelia
Organization:
Satelia
Study Overview
Official Title:
Evaluating the Effectiveness of Remote Patient Monitoring Satelia Cardio for Patients With Heart Failure TELESAT Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
TELESAT
Brief Summary:
The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring RPM program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France
The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival
Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition
Researchers will compare the following cohorts to see if RPM can improve their condition
Cohort 1 using RPM for follow-ups
Cohort 2 conventional care and not using any devices and solutions for the follow-ups
The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival
Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition
Researchers will compare the following cohorts to see if RPM can improve their condition
Cohort 1 using RPM for follow-ups
Cohort 2 conventional care and not using any devices and solutions for the follow-ups
Detailed Description:
TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022
The study was conducted using the French national health data system known as the Système National des Données de Santé SNDS which covers approximately 99 of the French population
The study was conducted using the French national health data system known as the Système National des Données de Santé SNDS which covers approximately 99 of the French population
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