Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG
Sponsor:
Lhôpital Nord-Ouest - Villefranche Villefranche sur Saône
Organization:
Lhôpital Nord-Ouest - Villefranche Villefranche sur Saône
Study Overview
Official Title:
Rentabilité Diagnostique Des Montres connectées Par Rapport au Holter ECG Externe Dans lExpertise Des Palpitations Fugaces Symptomatiques Sans Documentation électrocardiographique Per Critique
Status:
NOT_YET_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:
WAHOE
Brief Summary:
Palpitations are a frequent reason for consultation 16 of total volume and management in the emergency department
Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter combined with a stress test if symptoms are triggered by physical activity
The diagnostic difficulty lies in the frequency and duration of this transient symptom At the time of consultation the patient is often asymptomatic The initial strategy is to demonstrate an electrocardiographic trace during the attack in order to adapt management to the chosen etiology
The HOLTER ECG is the gold standard but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms
The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms They are widely adopted by the general population with ease of use by the individual and long monitoring times
The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies rate of identification of the causal arrhythmia at 6 months from the cardiological consultation
Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter combined with a stress test if symptoms are triggered by physical activity
The diagnostic difficulty lies in the frequency and duration of this transient symptom At the time of consultation the patient is often asymptomatic The initial strategy is to demonstrate an electrocardiographic trace during the attack in order to adapt management to the chosen etiology
The HOLTER ECG is the gold standard but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms
The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms They are widely adopted by the general population with ease of use by the individual and long monitoring times
The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies rate of identification of the causal arrhythmia at 6 months from the cardiological consultation
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01853-42 | OTHER | ANSM | None |