Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293241
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2006-02-16
Brief Title:
PreFER Managed Ventricular Pacing MVP For Elective Replacement
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
PreFER MVP for Elective Replacement
Status:
COMPLETED
Status Verified Date:
2015-06
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 purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator ICD patients with a history of right ventricular pacing
Detailed Description:
A number of clinical studies Danish I Danish II David MOST over the past few years have shown that in patients with intact atrioventricular AV conduction unnecessary chronic right ventricular RV pacing can cause a variety of detrimental effects including atrial fibrillation AF left ventricular LV dysfunction and congestive heart failure CHF These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic single-site apical ventricular stimulation
Therefore a new pacing modality Managed Ventricular Pacing MVP was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs
MVP is an atrial-based dual-chamber pacing mode that provides functional AAIR pacing with ventricular monitoring and back-up DDDR pacing only as needed during episodes of AV block
The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation
Therefore a new pacing modality Managed Ventricular Pacing MVP was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs
MVP is an atrial-based dual-chamber pacing mode that provides functional AAIR pacing with ventricular monitoring and back-up DDDR pacing only as needed during episodes of AV block
The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation
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