Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00547729
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2007-10-19
Brief Title:
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients HOMEOSTASIS
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients A Prospective Multi-center Non-randomized Open Label Study
Status:
COMPLETED
Status Verified Date:
2021-08
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:
HOMEOSTASIS
Brief Summary:
This study is a feasibility study of the HeartPOD Heart Failure Management System with DynamicRx HeartPOD system in patients with severe chronic congestive heart failure The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication The study will assess the safety reliability and preliminary efficacy of the HeartPOD system
Detailed Description:
Direct cardiac measurements may provide an accurate reliable and medically acceptable way of informing patients and physicians of worsening CHF prior to the development of symptoms This may enable physicians to take preventative measures and avoid hospitalization
This is a feasibility study to assess the safety reliability and preliminary efficacy of the HeartPOD Heart Failure Management System with DynamicRx This feasibility study will be performed in two phases The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the US
This is a feasibility study to assess the safety reliability and preliminary efficacy of the HeartPOD Heart Failure Management System with DynamicRx This feasibility study will be performed in two phases The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None