Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262119
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2005-12-04
Brief Title:
MINERVA MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
MINERVA MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Status:
COMPLETED
Status Verified Date:
2016-03
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:
None
Brief Summary:
The aim of this study is to test the impact of the managed ventricular pacing MVP mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death permanent atrial fibrillation and cardiovascular hospitalizations
Detailed Description:
Kristensen et al reported that AAIR pacing reduces atrial fibrillation AF development compared to DDDR pacing in sinus node disfunction patients
Several authors have shown that in patients with intact AV conduction unnecessary chronic RV pacing can cause detrimental effects such as AF left ventricular LV dysfunction and congestive heart failure These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects
The MVP mode present in the Medtronic pacemaker EnRhythm provides atrial based pacing with ventricular backup It operates in true AAIR mode it provides ventricular backup in case of a single conduction loss and converts to DDDR mode in case of persistent loss of AV conduction
Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death permanent AF cardiovascular hospitalizations
Several authors have shown that in patients with intact AV conduction unnecessary chronic RV pacing can cause detrimental effects such as AF left ventricular LV dysfunction and congestive heart failure These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects
The MVP mode present in the Medtronic pacemaker EnRhythm provides atrial based pacing with ventricular backup It operates in true AAIR mode it provides ventricular backup in case of a single conduction loss and converts to DDDR mode in case of persistent loss of AV conduction
Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death permanent AF cardiovascular hospitalizations
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