Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418314
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2007-01-03
Brief Title:
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Status:
COMPLETED
Status Verified Date:
2019-02
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 objective of this study is to demonstrate that frequent atrio-ventricular AVPV and inter-ventricular V-V delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care ie empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods
Detailed Description:
This is a prospective double-blinded multicenter randomized study
Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at 3 6 9 and 12 months
Patients will be randomized at enrollment to either Group 1 QuickOpt Group or Group 2 Control Group
Group 1 - The patients device is programmed to sequential biventricular pacing mode with AVPV and VV delays optimized using QuickOpt For Group 1 patients optimization using QuickOpt is performed at enrollment 3 month 6 month 9 month 12 month and at any unscheduled follow-up visits
Group 2 - The patients device is programmed to either simultaneous or sequential BiV pacing mode as per physicians discretion The AVPV and inter-ventricular VV delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care However the Group 2 patients can be optimized only once within the first 4 weeks post implant Any AVPV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations
Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at 3 6 9 and 12 months
Patients will be randomized at enrollment to either Group 1 QuickOpt Group or Group 2 Control Group
Group 1 - The patients device is programmed to sequential biventricular pacing mode with AVPV and VV delays optimized using QuickOpt For Group 1 patients optimization using QuickOpt is performed at enrollment 3 month 6 month 9 month 12 month and at any unscheduled follow-up visits
Group 2 - The patients device is programmed to either simultaneous or sequential BiV pacing mode as per physicians discretion The AVPV and inter-ventricular VV delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care However the Group 2 patients can be optimized only once within the first 4 weeks post implant Any AVPV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations
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