NCT00547729

Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)

Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 U.S.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	HeartPOD™ System	HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-10-23
• Last updated: 2021-09-02
• Results posted: 2021-08-06

Locations

7 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study