Interventricular Delay of Lumax HF-T for Heart Failure - Full Text View

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Device: Optimized interventricular delay biventricular pacing	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	122
Study Start Date:	July 2007
Study Completion Date:	August 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: Optimized interventricular delay biventricular pacing Lumax HF-T with optimized interventricular delay biventricular pacing Other Name: Optimized CRT, Interventricular delay
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.	Device: Optimized interventricular delay biventricular pacing Lumax HF-T with optimized interventricular delay biventricular pacing Other Name: Optimized CRT, Interventricular delay

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508391

Locations

United States, California
Solano Cardiology
Fairfield, California, United States, 94533
Cardiac Arrhythmia Associates
La Jolla, California, United States, 92307
Sansum Clinic
Santa Barbara, California, United States, 93110
Cardiology Associates Medical Group
Ventura, California, United States, 93003
United States, Georgia
Cardiac Disease Specialists, P.C.
Atlanta, Georgia, United States, 30309
Georgia Arrhythmia Consultants
Macon, Georgia, United States, 31201
United States, Maryland
Fananapazir
Cumberland, Maryland, United States, 21502
United States, Massachusetts
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Michigan
Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48601
United States, Missouri
Gateway Cardiology
St. Louis, Missouri, United States, 63128
SSM Medical Group
St. Louis, Missouri, United States, 63117
United States, Oregon
Salem Cardiology
Salem, Oregon, United States, 97302
United States, South Carolina
Palmetto Cardiology
Columbia, South Carolina, United States, 29204
Pee Dee Cardiology
Florence, South Carolina, United States, 29505
Cardiology Consultants
Spartanburg, South Carolina, United States, 29303
United States, Texas
Lone Star Heart Center
Amarillo, Texas, United States, 79106
Cardiac Associates of Dallas
Dallas, Texas, United States, 75230
United States, Washington
Yakima Heart Center
Yakima, Washington, United States, 98902
Switzerland
University Hospital Zurich
Zurich, Switzerland

Sponsors and Collaborators

Biotronik, Inc.

More Information

No publications provided

Responsible Party:	Clay Cohorn, Clinical Studies Engineer II, Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00508391 History of Changes
Other Study ID Numbers:	G070019
Study First Received:	July 26, 2007
Results First Received:	October 27, 2009
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013