Advance Cardiac Resynchronization Therapy (CRT) Registry

Study Overview
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Brief Summary
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The intent of this registry is to understand comprehensive clinical care strategies for Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world clinical practice.

Detailed Description
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Patients who are implanted CRT devices will be enrolled in the study. Once implanted, all patients will be followed at every 3 months for the first 12 months from the implant. The responder/non-responder evaluation will occur at 6 months from the implant date. The criteria used for determining the response to CRT will be captured. During the office follow-up visits, arrhythmic episode diagnoses, device data and stored electrogram will be collected. All clinical events such as hospitalization for heart failure (HF), all-cause hospitalizations, and all-cause death will also be collected. For patients who are non-responders to CRT, any re-optimization of the device, i.e., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (LV) lead repositioning and pacing vector reconfiguration as well as modified/new clinical therapies administered in an attempt to improve HF condition will be collected.

Official Title
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Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CRT Patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient willing and able to sign informed consent Patients implanted with any market-approved St. Jude Medical CRT-D/P device with no prior LV lead placement Exclusion Criteria: Are likely to undergo heart transplantation within the next 12 months Are less than 18 years of age Are pregnant or planning to become pregnant during the duration of the study Are currently participating in a clinical investigation that includes an active treatment arm Have a life expectancy of less than 6 months

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT patients<br>Patients who have received any market approved St Jude Medical CRT-D or CRT-P device | Device: CRT Patients<br>* This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.<br>* Other names: St Jude Medical, Any approved CRT device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response | The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score. Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.) | 6 months | 
| Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT | Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status. | 6 months | 
| Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months |  | Between 6 and 12 months | 
| Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months | Improvement in NYHA Class determined by improvement by at least 1 class. | Between 6 and 12 months |