FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Not Applicable

Completed

• Conditions: Heart Failure; Cardiac Arrhythmias
• Interventions: Device: QuickOpt; Device: Control

• Registration Number: NCT00418314
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-03
• Study First Posted: 2007-01-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2014-05-14
• Results First Submitted QC: 2016-01-05
• Results First Posted: 2016-02-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1647

Inclusion Criteria

• Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM) CRT¬D device with VV timing and a compatible lead system.
• Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
• Patient has the ability to independently comprehend and complete a QOL questionnaire.

Exclusion Criteria

• Patient has an epicardial ventricular lead system.
• Patient has the ability to walk ≥ 450 meters in 6 minutes
• Patient has limited intrinsic atrial activity (≤ 40 bpm).
• Patient has persistent or permanent atrial fibrillation (AF).
• Patient has a 2° or 3° heart block.
• Patient's life expectancy is less than 1 year.
• Patient is pregnant.
• Patient is on IV inotropic agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QuickOpt (Treatment)	QuickOpt	Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
Control	Control	Empiric programming or one-time optimization using a non-IEGM method.

Primary Outcome Measures

Name	Time	Method
Heart Failure Clinical Composite Score	12 months	The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.

Secondary Outcome Measures

Name	Time	Method
All Cause, Cardiovascular and Heart Failure Hospitalization	12 months
All-cause, Cardiovascular and Heart Failure Mortality;	12 months

Trial Locations

Locations (2)

Cedars Sinai Hospital; 🇺🇸 Los Angeles, California, United States

Ohio State Univeristy; 🇺🇸 Columbus, Ohio, United States