Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570902
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Prosective WCD Post CABG Registry CABG Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prosective WCD Post CABG Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to observe the rate of recovery of ventricular function EF35 after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator WCD post-surgery prior to being discharged after hospitalization as part of standard clinical care
Detailed Description:
The primary objective of this study is to determine the rate of recovery of ventricular function EF35 in patients with ischemic heart failure with reduced ejection fraction EF 35 after undergoing first time coronary artery bypass grafting CABG procedure while being treated with guideline-directed medical therapy GDMT It is anticipated that more patients will have EF recovery as compared to a retrospective register where 54 of isolated CABG patients had EF recovery by end of WCD use Kuehn et al 2022 mostly driven by the modern improved usage of GDMT drugs
This study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with HFrEF at hospital discharge to test the hypothesis that EF recovery will be improved by end of WCD wear due to increased usage of GDMT The study will target 20 female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20
This study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with HFrEF at hospital discharge to test the hypothesis that EF recovery will be improved by end of WCD wear due to increased usage of GDMT The study will target 20 female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None