Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187278
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2005-09-13
Brief Title:
Biopace Study Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization
Status:
COMPLETED
Status Verified Date:
2021-01
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 primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing left ventricular ejection fraction without limit or any QRS duration will profit from the prevention of ventricular desynchronisation
Detailed Description:
The study will be performed as a controlled single-blind international multicenter prospective randomized parallel group design
In order to pragmatically examine the effectiveness of biventricular pacing in patients with an indication for ventricular pacing the study group with biventricular pacing is compared to a control group with standard pacemakers which only allow univentricular right ventricular stimulation as it has been the standard outside of clinical studies until so far
In order to pragmatically examine the effectiveness of biventricular pacing in patients with an indication for ventricular pacing the study group with biventricular pacing is compared to a control group with standard pacemakers which only allow univentricular right ventricular stimulation as it has been the standard outside of clinical studies until so far
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None