Clinical trial NCT00418314: FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Official title: FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmias
Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 1647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart Failure Clinical Composite Score
timeFrame: 12 months
Secondary outcomes:
measure: All-cause, Cardiovascular and Heart Failure Mortality;
timeFrame: 12 months
measure: All Cause, Cardiovascular and Heart Failure Hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Hospital
state: California
city: Columbus
country: United States
facility: Ohio State Univeristy
state: Ohio
Study officials:
affiliation: Ohio State University, Columbus, OH, USA
name: William Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nouvelles Cliniques Nantaises, Nantes, France
name: Daniel Gras, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034.