500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:18 and older
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
Sponsor: Biotronik, Inc.
Phase: Phase 2
Trial ID: NCT00508391
Not Accepting Healthy Volunteers