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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,529
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response
1. 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. 2. Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)
Time frame: 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.
Time frame: 6 months
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months
Time frame: 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.
Time frame: Between 6 and 12 months
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Alabama Cardiovascular Group, P.C.
Birmingham, Alabama, United States
*Heart Center Research, LLC.
Huntsville, Alabama, United States
Cardiovascular Consultants Ltd
Glendale, Arizona, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Comprehensive Cardiovascular
Bakersfield, California, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Cardiac Rhythm Specialist
Northridge, California, United States
Claudio Bonometti MD, Inc
Santa Barbara, California, United States
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