Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236776
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-11-10
Brief Title:
AWARE Registry Wearable ECG in Structural Heart Interventions
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring AWARE Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This study is a multi-center Sinchon Severance hospital Gangnam Severance hospital prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale Transthoracic echocardiography will be performed before the procedure immediately after and at 6 18 30 months after the procedure Wearable ECG monitoring 3 days will be performed before the procedure or immediately after procedure Demographic laboratory hemodynamic data during procedure and non-invasive imaging dat are obtained
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?:
None
Is an FDA AA801 Violation?:
None