Heart Failure, Ventricular Arrhythmias
Conditions
Brief summary
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
Detailed description
The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated. This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.
Interventions
DEVICECRT device implant
CRT device-recipients
Sponsors
Abbott Medical Devices
Northwestern University
VA Pittsburgh Healthcare System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets current clinical indications for CRT-D therapy * Patient is 18 years old or older * Ability to independently comprehend and complete all QOL questionnaires * Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath * Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
Exclusion criteria
* Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure. * Myocardial infarction in the last 3 weeks * Unstable angina in the last 3 weeks * Status 1 classification for cardiac transplantation * Currently participating in a clinical trial that includes an active treatment arm * Life expectancy of less than 12 months. * Recent (within 1 week) administration of Nesiritide™ or inotropes * Patients in whom revascularization is expected * Patient is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 6-minute hall walk distance between baseline and subsequent follow-up | 12 months |
| Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36) | 12 months |
| The occurrence of either death (all-cause) or first HF hospitalization. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life | 12 months |
| Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index | 12 months |
| Cause-specific mortality | 12 months |
Countries
United States
Outcome results
None listed