NCT00418314

FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,647 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 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.

Conditions

• Cardiac Arrhythmias
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Control	Empiric programming or one-time optimization using a non-IEGM method.
DEVICE	QuickOpt	Frequent optimization using QuickOpt to optimize AV/PV and VV delays.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-01-04
• Last updated: 2019-02-19
• Results posted: 2016-02-04

Locations

2 sites across 1 country: United States