Clinical trial NCT00508391: Interventricular Delay of Lumax HF-T for Heart Failure
Official title: Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
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
timeFrame: 60 days after enrollment
measure: 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
timeFrame: 60 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Solano Cardiology
state: California
city: La Jolla
country: United States
facility: Cardiac Arrhythmia Associates
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Atlanta
country: United States
facility: Cardiac Disease Specialists, P.C.
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Cumberland
country: United States
facility: Fananapazir
state: Maryland
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: St. Louis
country: United States
facility: SSM Medical Group
state: Missouri
city: St. Louis
country: United States
facility: Gateway Cardiology
state: Missouri
city: Salem
country: United States
facility: Salem Cardiology
state: Oregon
city: Columbia
country: United States
facility: Palmetto Cardiology
state: South Carolina
city: Florence
country: United States
facility: Pee Dee Cardiology
state: South Carolina
city: Spartanburg
country: United States
facility: Cardiology Consultants
state: South Carolina
city: Amarillo
country: United States
facility: Lone Star Heart Center
state: Texas
city: Dallas
country: United States
facility: Cardiac Associates of Dallas
state: Texas
city: Yakima
country: United States
facility: Yakima Heart Center
state: Washington
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References: