Heart Failure
Conditions
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.
Interventions
DEVICECRT Patients
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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 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 | Between 6 and 12 months | Improvement in NYHA Class determined by improvement by at least 1 class. |
Countries
Argentina, Brazil, China, Colombia, India, Japan, Puerto Rico, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRT Patients Patients who have received any market approved St Jude Medical CRT-D or CRT-P device
CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from a CRT device. | 1,524 |
| Total | 1,524 |
Baseline characteristics
| Characteristic | CRT Patients |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 11.5 |
| History of Atrial Fibrillation (AF) | 583 Participants |
| Left Ventricular Ejection Fraction % (EF) | 29.2 Percent blood ejected STANDARD_DEVIATION 11.2 |
| New York Heart Association (NYHA) Class NYHA Class I | 45 Participants |
| New York Heart Association (NYHA) Class NYHA Class II | 335 Participants |
| New York Heart Association (NYHA) Class NYHA Class III | 1033 Participants |
| New York Heart Association (NYHA) Class NYHA Class IV | 109 Participants |
| Race/Ethnicity, Customized Race/Ethnic category American Indian or Alaska Native | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnic category Asian | 327 Participants |
| Race/Ethnicity, Customized Race/Ethnic category Black or African American | 78 Participants |
| Race/Ethnicity, Customized Race/Ethnic category Hispanic or Latino | 113 Participants |
| Race/Ethnicity, Customized Race/Ethnic category Other | 21 Participants |
| Race/Ethnicity, Customized Race/Ethnic category White or Caucasian | 883 Participants |
| Region of Enrollment Argentina | 9 participants |
| Region of Enrollment Colombia | 27 participants |
| Region of Enrollment India | 205 participants |
| Region of Enrollment United States | 1147 participants |
| Sex: Female, Male Female | 480 Participants |
| Sex: Female, Male Male | 1044 Participants |
| Type of Cardiomyopathy Ischemic | 597 Participants |
| Type of Cardiomyopathy None | 212 Participants |
| Type of Cardiomyopathy Non-Ischemic | 709 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 132 / 1,524 |
| other Total, other adverse events | 403 / 1,524 |
| serious Total, serious adverse events | 226 / 1,524 |
Outcome results
Primary
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
Population: The analysis population included any subject who had a 6-month CRT evaluation or died due to a cardiovascular cause prior to 6 months. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CRT Patients | Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response | Site Determined CRT Response | 1061 Participants |
| CRT Patients | Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response | CCS Deteremined CRT Response | 900 Participants |
Primary
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
Population: The analysis population included any subject with a completed 6-month CRT evaluation. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Device LV Pacing Change | 63 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Other Treatments | 71 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Treatment for Comorbidities | 100 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Bi-Ventricular Pacing Increase | 43 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Device AV/VV Intervals Optimized | 197 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Other Device Parameters Changed | 88 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Medication Changed | 319 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Arrythmia Treatments | 79 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Diet Compliance | 53 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | Medication Compliance | 42 Participants |
| CRT Patients | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | HF Education Provided | 328 Participants |
Primary
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
Population: Only subjects who had evaluable data at 6 and 12 months are included. Thus, fewer subjects than those who completed the 6-month and 12-month visits were analyzable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRT Patients | Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months | 93 Participants |
| Site CRT Non-Responders | Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months | 34 Participants |
Primary
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
Population: The analysis population included any subject with a completed 6-month CRT evaluation. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CRT Patients | Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT | Clinical Events Used | 858 Participants |
| CRT Patients | Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT | Echocardiographic Remodeling Used | 431 Participants |
| CRT Patients | Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT | Clinical Functional Assessment Used | 847 Participants |