Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310031
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-07
Brief Title:
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Sponsor:
Redacted
Organization:
Redacted
Study Overview
Official Title:
Investigation of a Novel MagNetically Levitated VAD for the Treatment of RefractOry Left Ventricular HeArT FailurE
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
True
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INNOVATE
Brief Summary:
The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced refractory left ventricular heart failure
Detailed Description:
The INNOVATE Trial is a prospective non-blinded randomized controlled multi-center non-inferiority study to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 HM3 LVAS Abbott when used for the treatment of advanced refractory left ventricular heart failure It is the first clinical study to compare two left ventricular assist devices LVAD that belong to the same category of fully magnetically levitated LVAD
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