FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Heart Failure Clinical Trial

Official title: FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Status Completed

Clinical Trial Summary

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 cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).

Clinical Trial 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 patient's device is programmed to sequential biventricular 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 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 AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations. ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias
• Heart Failure

• NCT number: NCT00418314
• Study type: Interventional
• Source: Abbott Medical Devices
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Completion date: September 2009