Phase 2
N=122
Interventricular Delay of Lumax HF-T for Heart Failure
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00508391 ↗Enrolled (actual)
122
Serious AEs
6.6%
Results posted
Jan 2010
Primary outcome: Primary: Percentage of Subjects Classified as "Not Worsened" for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing — 65; 62; 63 Percent of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Optimized interventricular delay biventricular pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotronik, Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Classified as "Not Worsened" for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing |
65; 62; 63 | — |
| PRIMARY Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device |
100; 100; 100 | — |
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
Data sourced from ClinicalTrials.gov (NCT00508391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.