NCT00354159

Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)

Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic HF (REDUCEhf)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the force with which the heart pumps blood (heart pressures). When combined with the ICD, the device has the additional ability to send a strong electrical impulse, or shock, to the heart when it detects dangerously fast heartbeats to return it to a normal rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest area. This study will also determine how doctors use the information related to heart pressures in the management of heart failure.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)	Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.

Timeline

• Start date: 2006-04-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2006-07-20
• Last updated: 2012-08-09
• Results posted: 2012-08-09

Locations

52 sites across 1 country: United States