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Interventricular Delay of Lumax HF-T for Heart Failure

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ClinicalTrials.gov Identifier: NCT00508391
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : January 18, 2010
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Biotronik, Inc.

July 26, 2007
July 30, 2007
October 27, 2009
January 18, 2010
January 26, 2010
July 2007
December 2008   (Final data collection date for primary outcome measure)
  • 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 [ Time Frame: 60 days after enrollment ]
  • 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 [ Time Frame: 60 days after enrollment ]
  • Responder classification of changes in the Minnesota Living with Heart Failure questionnaire and 6-minute walk distance between periods of SIM and OPT [ Time Frame: One and two months after enrollment ]
  • Adverse events that require additional invasive intervention to resolve, specifically related to the V-V delay feature of the Lumax HF-T [ Time Frame: Within two months after enrollment ]
Complete list of historical versions of study NCT00508391 on ClinicalTrials.gov Archive Site
Not Provided
Adverse events related to the implanted system including the Lumax HF-T and the legally marketed leads [ Time Frame: WIthin six month after enrollment ]
Not Provided
Not Provided
 
Interventricular Delay of Lumax HF-T for Heart Failure
Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Congestive Heart Failure
Device: Optimized interventricular delay biventricular pacing
Lumax HF-T with optimized interventricular delay biventricular pacing
Other Name: Optimized CRT, Interventricular delay
  • Experimental: Simultaneous 1st, Optimized 2nd
    Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
    Intervention: Device: Optimized interventricular delay biventricular pacing
  • Experimental: Optimized 1st, Simultaneous 2nd
    Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
    Intervention: Device: Optimized interventricular delay biventricular pacing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
117
August 2009
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland,   United States
 
 
NCT00508391
G070019
No
Not Provided
Not Provided
Clay Cohorn, Clinical Studies Engineer II, Biotronik, Inc.
Biotronik, Inc.
Not Provided
Not Provided
Biotronik, Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP