FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Study Overview
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Brief Summary
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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
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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.

Official Title
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FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

Conditions
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Cardiac Arrhythmias, Heart Failure

Intervention / Treatment
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* Device: Control
* Device: QuickOpt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QuickOpt (Treatment)<br>Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. | Device: QuickOpt<br>* Frequent optimization using QuickOpt to optimize AV/PV and VV delays.<br>|
| Active Comparator: Control<br>Empiric programming or one-time optimization using a non-IEGM method. | Device: Control<br>* Empiric programming or one-time optimization using a non-IEGM method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Clinical Composite Score | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause, Cardiovascular and Heart Failure Mortality; |  | 12 months | 
| All Cause, Cardiovascular and Heart Failure Hospitalization |  | 12 months |