Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)

Study Overview
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Brief Summary
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The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.

Detailed Description
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SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.

Official Title
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SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

Conditions
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Heart Failure

Intervention / Treatment
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* Device: AV Delay programming through cardiac resynchronization therapy
* Device: AV Delay programming through cardiac resynchronization therapy
* Device: AV Delay programming through cardiac resynchronization therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study Patients who are on optimal and stable pharmacologic therapy Patients who are expected to be in sinus rhythm at the time of implant Patients who have a life expectancy of more than 360 days, per physician's discretion Patients who are geographically stable and willing to comply with the required follow-up schedule Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days Patients who have previously received cardiac resynchronization therapy Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study Patients who currently have or who are likely to receive a tricuspid valve prosthesis Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking Patients who are pregnant or planning to become pregnant during the study Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study

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 |
| --- | --- |
| Active Comparator: Echo optimized AV delay<br>Echo optimized AV delay | Device: AV Delay programming through cardiac resynchronization therapy<br>* All subjects in this trial receive the same device. For the purpose of this trial. intervention is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.<br>|
| Active Comparator: Algorithm optimized AV delay<br>Algorithm optimized AV delay | Device: AV Delay programming through cardiac resynchronization therapy<br>* All subjects in this trial receive the same device. For the purpose of this trial. intervention is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.<br>|
| Active Comparator: Fixed AV Delay<br>Fixed AV Delay | Device: AV Delay programming through cardiac resynchronization therapy<br>* All subjects in this trial receive the same device. For the purpose of this trial. intervention is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular End-systolic Volume (LVESV) | Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints Will Include Structural and Functional Measures |  | Chronic | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, HF, Cardiac Resynchronization Therapy, CRT, Optimization, SmartDelay, Echocardiography, AV Delay