Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281099
Status:
TERMINATED
Last Update Posted:
2010-08-03
First Post:
2006-01-20
Brief Title:
Managed Ventricular Pacing MVP Trial
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
MVP Trial Managed Ventricular Pacing MVP Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute VVI 40 Pacing Trial
Status:
TERMINATED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to reach statistical significance toward primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MVP
Brief Summary:
The purpose of the study is to compare two device settings sets of instructions used by the ICD The Implantable Cardiac Defibrillator ICD can be set to use one wire top or bottom of the heart or two wires top and bottom The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure
Detailed Description:
Recent research supports the hypothesis that reducing the amount of pacing in the lower right chamber of the heart may prevent the progression of congestive heart failure CHF in some implantable cardioverter defibrillator ICD patients CHF refers to symptoms shortness of breath fatigue fluid overload caused by decreased pumping action of the heart muscle The ICD can be set to use one wire top or bottom of the heart or two wires top and bottom Both settings allow the heart to beat more naturally using its own electrical signals Two device settings will be compared Managed ventricular pacing MVP will allow the ICD to use both wires only as necessary This setting allows the ICD to send electrical signals to the top and bottom chambers of the heart if needed The other setting ventricular pacing VVI will allow the ICD to operate the bottom chamber of the heart if it is needed
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