multipoint pacing ide study

Conditions: Heart Failure

Summary: this ide study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with mpp compared to patient treatment with standard biv pacing at 9 months. the study will be conducted at a maximum of 50 investigational centers located in the united states. a maximum of 506 subjects implanted with the quadripolar cardiac resynchronization therapy device (crt-d) system will be enrolled in the study.

all subjects will undergo a 2 dimensional echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. at implant, the final lv pacing configuration is programmed using any one of the 10 available pacing vectors. the paced/sensed atrioventricular (av) and interventricular (vv) delays may be optimized as per the site's standard of care. subjects will continue to receive biv therapy until the 3-month follow-up visit. at the 3-month visit, responder status between enrollment and 3 months will be assessed using the clinical composite score (ccs). all subjects that are "improved" using the definition outlined in the ccs will be grouped together as responders. all subjects that are "worsened" or "unchanged" using the definitions outlined in the ccs will be considered as non-responders. all subjects will undergo acute measurement of cardiac performance (e.g., echocardiography) at various mpp combinations compared to biv pacing. only subjects with "equal or better" echocardiographic measurements (i.e., ea vti measurements) with mpp feature on compared to biv pacing will be randomized in a 1:1 ratio to one of the two arms - biv arm or mpp arm. at the 9-month visit, responder status will be evaluated once again using the ccs and compared to the status at 3 months.

Eligibility criteria:
inclusion criteria: * meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s) * receiving a new crt implant or undergoing an upgrade from an existing icd or pacemaker implant with no prior lv lead placement * have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations exclusion criteria: * have had a recent cerebrovascular accident (cva) or transient ischemic attack (tia) within 3 months of enrollment * have an existing class i recalled lead * have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate * have a classification of status 1 for cardiac transplantation or consideration for transplantation over the next 9 months * have permanent atrial fibrillation (af) * have undergone a cardiac transplantation within 40 days of enrollment * have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant. * are currently participating in a clinical investigation that includes an active treatment arm * are pregnant or planning to become pregnant during the duration of the study * have a life expectancy of less than 9 months due to any condition * are less than 18 years of age