Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03016754
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2017-01-04
Brief Title:
Heart Failure Optimization Study
Sponsor:
Zoll Medical Corporation
Organization:
Zoll Medical Corporation
Study Overview
Official Title:
Heart Failure Optimization Study
Status:
COMPLETED
Status Verified Date:
2022-06
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:
HF-Opt
Brief Summary:
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure HF patients to test the hypothesis that additional Ejection Fraction EF recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy GDMT is achieved Although the study doesnt start until day 90 all eligible consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator WCD use The pre-study registry will allow us to collect early 90 day outcomes and data in those patients who are likely to be eligible for the study at day 90 or are eligible but refuse the study at day 90
Detailed Description:
This study will be conducted at thirty to sixty sites initially in US and Europe It will be used to observe the rate of recovery of ventricular function EF35 between 90 and 180 days in newly diagnosed HF patients who were prescribed the WCD 10 days post-discharge after hospitalization for a primary reason of new onset HF 30 days since first HF hospitalization with ischemic or non-ischemic cardiomyopathy and have already used a WCD for 90 14 days For the first 90 days of WCD use patients will be enrolled in a pre-study registry The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge with the option for longer use under physician discretion Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study
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