interventricular delay of lumax hf-t for heart failure

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to demonstrate that the safety and efficacy of the lumax hf-t with optimized interventricular delay biventricular pacing (opt) is non-inferior to the lumax hf-t with simultaneous biventricular pacing (sim) in patients with heart failure requiring cardiac resynchronization therapy.

this study is a randomized, double-blinded, crossover, multi-center, prospective trial. the study will consist of up to 122 subjects who require treatment of advanced heart failure through cardiac resynchronization therapy (crt) with back-up defibrillation capabilities. eligible patients will have a successfully implanted biotronik lumax hf-t crt-d system and have received simultaneous biventricular pacing for a minimum of 90 days prior to enrollment. the 90-day period is being required to allow the treatment effect of crt therapy with sim to be complete and to ensure the patient is receiving a stable and optimal chf medical regimen. the patients will have the interventricular delay feature programmed after a standardized optimization procedure. patients, along with study personnel evaluating the study endpoint measures, will be blinded to the type of crt therapy delivered during the study follow-up period.

Eligibility criteria:
inclusion criteria: * meet the indications for therapy * successfully implanted with a biotronik lumax hf-t crt-d system and have received sim for a minimum of 30 days prior to enrollment. a successful implantation is defined as having a measured lv pacing threshold which allows for a minimum 1-volt safety margin without any phrenic nerve stimulation at the time of enrollment. * treated with stable and optimal chf medications, which includes an ace inhibitor (ace-i) or angiotensin receptor blocker (arb) at therapeutic dose for 1 month prior to enrollment, if tolerated, and a beta blocker that is approved and indicated for hf for 3 months prior to enrollment, if tolerated, with a stable dosage for 1 month prior to enrollment. if the patient is intolerant of ace-i or beta blockers, documented evidence must be available. eplerenone requires dosage stability for 1 month prior to enrollment. diuretics may be used as necessary to keep the patient euvolemic. therapeutic equivalence for ace-i substitutions is allowed within the enrollment stability timeliness. stable is defined as no more than a 100% increase or a 50% decrease in dose. * age ≥ 18 years * able to understand the nature of the study and give informed consent * able to complete all testing required by the clinical protocol, including the 6-minute walk test and qol questionnaire * available for follow-up visits on a regular basis at the investigational site exclusion criteria: * meet one or more of the contraindications * have a life expectancy of less than 6 months * expected to receive heart transplantation within 6 months * have had more than 1 chf-related hospitalization within past 30 days * currently receiving iv inotropic medications * chronic atrial fibrillation * enrolled in another cardiovascular or pharmacological clinical investigation, except for fda required post-market registries * any condition preventing the patient from being able to perform required testing * presence of another life-threatening, underlying illness separate from their cardiac disorder