Advance Cardiac Resynchronization Therapy (CRT) Registry

Completed

Conditions: Heart Failure

Registration Number: NCT01805154

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1529

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT	6 months	Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.
Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months	Between 6 and 12 months	Improvement in NYHA Class determined by improvement by at least 1 class.
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 CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response	6 months	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.)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (69): 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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Alabama Cardiovascular Group, P.C.
🇺🇸Birmingham, Alabama, United States