Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT04338503
Status:
UNKNOWN
Last Update Posted:
2023-03-30
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanically Optimizing Cardiac Preload in Heart Failure Patients
Sponsor:
Cardioflow Technologies, LLC
Organization:
Study Overview
Official Title:
Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
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:
The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: