Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354159
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2006-07-19
Brief Title:
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure HF REDUCEhf
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic HF REDUCEhf
Status:
COMPLETED
Status Verified Date:
2012-08
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:
REDUCEhf
Brief 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 IHMICD 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
Detailed Description:
None
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