Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

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.

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