FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-IEGM optimization methods).
Patient Has a Standard Indication for a CRT-D
Device: Optimization of atrio-ventricular (AV/PV) and inter-ventricular (V-V) delays
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||FREEDOM - A Frequent Optimization Study Using the QuickOpt Method|
- Heart Failure clinical composite score
- All-cause, cardiovascular and heart failure mortality; All-cause, cardiovascular and heart failure hospitalizations
- Additional Data : 6 minute hall walk; Quality-of-life (QOL) score; Changes in AV/PV and VV delays; Time required for optimization; Frequency of atrial and ventricular arrhythmias; Percent atrial and ventricular pacing
|Study Start Date:||October 2006|
- 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 patient's device is programmed to sequential BiV pacing mode with AV/PV 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 patient's device is programmed to either simultaneous or sequential BiV pacing mode as per physician's discretion. The AV/PV and 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 AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations.
|United States, California|
|Cedars Sinai Hospital|
|Los Angeles, California, United States|
|United States, Ohio|
|Ohio State Univeristy|
|Columbus, Ohio, United States|
|Principal Investigator:||William Abraham, MD||Ohio State University, Columbus, OH, USA|
|Principal Investigator:||Daniel Gras, MD||Nouvelles Cliniques Nantaises, Nantes, France|