- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508391
Interventricular Delay of Lumax HF-T for Heart Failure
January 21, 2010 updated by: Biotronik, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zurich, Switzerland
- University Hospital Zurich
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-
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California
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Fairfield, California, United States, 94533
- Solano Cardiology
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La Jolla, California, United States, 92307
- Cardiac Arrhythmia Associates
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Santa Barbara, California, United States, 93110
- Sansum Clinic
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Ventura, California, United States, 93003
- Cardiology Associates Medical Group
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Georgia
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Atlanta, Georgia, United States, 30309
- Cardiac Disease Specialists, P.C.
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Macon, Georgia, United States, 31201
- Georgia Arrhythmia Consultants
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Maryland
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Cumberland, Maryland, United States, 21502
- Fananapazir
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Massachusetts
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Boston, Massachusetts, United States, 02135
- St. Elizabeth's Medical Center
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Michigan
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Saginaw, Michigan, United States, 48601
- Michigan CardioVascular Institute
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Missouri
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St. Louis, Missouri, United States, 63117
- SSM Medical Group
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St. Louis, Missouri, United States, 63128
- Gateway Cardiology
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Oregon
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Salem, Oregon, United States, 97302
- Salem Cardiology
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South Carolina
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Columbia, South Carolina, United States, 29204
- Palmetto Cardiology
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Florence, South Carolina, United States, 29505
- Pee Dee Cardiology
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Spartanburg, South Carolina, United States, 29303
- Cardiology Consultants
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Texas
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Amarillo, Texas, United States, 79106
- Lone Star Heart Center
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Dallas, Texas, United States, 75230
- Cardiac Associates of Dallas
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Washington
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Yakima, Washington, United States, 98902
- Yakima Heart Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Lumax HF-T with optimized interventricular delay biventricular pacing
Other Names:
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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.
|
Lumax HF-T with optimized interventricular delay biventricular pacing
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM).
The hypothesis is evaluated based on a responder classification.
Subjects are classified "not worsened" if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM.
The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL.
Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105.
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60 days after enrollment
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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
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The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device.
These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.
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60 days after enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
July 26, 2007
First Submitted That Met QC Criteria
July 26, 2007
First Posted (Estimate)
July 30, 2007
Study Record Updates
Last Update Posted (Estimate)
January 26, 2010
Last Update Submitted That Met QC Criteria
January 21, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G070019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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