InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
1 other identifier
interventional
238
1 country
34
Brief Summary
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Mar 2003
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 28, 2005
CompletedFirst Posted
Study publicly available on registry
December 30, 2005
CompletedDecember 21, 2007
December 1, 2007
December 28, 2005
December 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and effectiveness of the InSync III Marquis Model 7279 in heart failure patients who were indicated for an ICD
Secondary Outcomes (1)
Rate of oxygen uptake (consumption) measured during exercise, all adverse events, echocardiographic assessments (tests done using ultra sound to examine the health of the heart), and device performance
Interventions
Eligibility Criteria
You may qualify if:
- Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined the need for an implantable cardioverter defibrillator.
- 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.)
You may not qualify if:
- Subject has unstable chest pain, heart surgery within past 3 months
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Anchorage, Alaska, United States
Unknown Facility
Phoenix, Arizona, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Jacksonville, Florida, United States
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Pensacola, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Beech Grove, Indiana, United States
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Burlington, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Aiken, South Carolina, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Falls Church, Virginia, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Related Publications (1)
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.
PMID: 23137504DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 28, 2005
First Posted
December 30, 2005
Study Start
March 1, 2003
Study Completion
April 1, 2005
Last Updated
December 21, 2007
Record last verified: 2007-12