Interventricular Delay of Lumax HF-T for Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Optimized interventricular delay biventricular pacing
Intervention description: Lumax HF-T with optimized interventricular delay biventricular pacing
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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