InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
NCT ID: NCT00271232
Last Updated: 2007-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
238 participants
INTERVENTIONAL
2003-03-31
2005-04-30
Brief Summary
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The InSync III Marquis device can change the timing of when the left and right ventricles of the heart are paced to beat. This is called "V to V timing". V to V timing may further improve the pumping function of the heart. The purpose of this study is to determine whether or not this V to V timing feature of the InSync III Marquis system is safe and effective.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Cardiac resynchronization therapy
Eligibility Criteria
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Inclusion Criteria
Subject is on optimal medical treatment for heart failure.
Subject has reduced left ventricular ejection fraction (LVEF≤35%). (LVEF is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)
Subject who has heart failure which severely limits daily activities (NYHA Class III) or subject who has severe heart failure and should always be resting (NYHA Class IV)
Subject who has a QRS≥130ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (more than 120 ms) suggests that there is a conduction problem (or block) in the ventricles.)
Subjects with a left ventricular end diastolic dimension (LVEDD≥55mm). (The LVEDD is a measurement taken during an echocardiogram that is one indication of the health of the left ventricle.)
Exclusion Criteria
Subject has liver function tests greater than 3 times normal limits
Subject has chronic (permanent) atrial arrhythmias (fast heart beats in the upper chamber(s) of the heart)
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Locations
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Anchorage, Alaska, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Stanford, California, United States
Jacksonville, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Beech Grove, Indiana, United States
Burlington, Massachusetts, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Aiken, South Carolina, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Falls Church, Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Abraham WT, Leon AR, St John Sutton MG, Keteyian SJ, Fieberg AM, Chinchoy E, Haas G. Randomized controlled trial comparing simultaneous versus optimized sequential interventricular stimulation during cardiac resynchronization therapy. Am Heart J. 2012 Nov;164(5):735-41. doi: 10.1016/j.ahj.2012.07.026. Epub 2012 Oct 2.
Other Identifiers
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199
Identifier Type: -
Identifier Source: org_study_id