InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
NCT ID: NCT00273182
Last Updated: 2013-08-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1999 participants
OBSERVATIONAL
2002-03-31
2011-04-30
Brief Summary
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When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.
The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
Patients implanted with InSync Model 8040, InSync III Model 8042 , or Medtronic CRT-D system. A total of 1999 subjects were enrolled in the study. Of them, 1738 had successful post market implants of InSync Model 8040 (601 subjects), InSync III Model 8042 (512 subjects) and CRT-D devices (625 subjects). The rest 262 subjects came from two pre-market studies: the MIRACLE study added 141 subjects to InSync Model 8040, and the InSync III study added 121 subjects to the InSync III Model 8042. A total of 1014 subjects completed the study through 36 month follow up. Follow-up of 1000 subjects was required by the FDA to satisfy the conditions of approval.
InSync Model 8040
Subjects with sucessful implants of InSync Model 8040.
InSync III Model 8042
Subjects with successful implants of InSync III Model 8042
Interventions
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InSync Model 8040
Subjects with sucessful implants of InSync Model 8040.
InSync III Model 8042
Subjects with successful implants of InSync III Model 8042
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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InSync Registry Study Leader
Role: STUDY_CHAIR
Medtronic
Locations
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Birmingham, Alabama, United States
Peoria, Arizona, United States
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
Long Beach, California, United States
Napa, California, United States
Oxnard, California, United States
San Diego, California, United States
Yuba City, California, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Rockford, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Salisbury, Maryland, United States
Silver Spring, Maryland, United States
Boston, Massachusetts, United States
Worchester, Massachusetts, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Marquette, Michigan, United States
Saginaw, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Hattiesburg, Mississippi, United States
Tupelo, Mississippi, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Saint Joseph, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Lincoln, Nebraska, United States
Newark, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
High Pointe, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Mayfield Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Doylestown, Pennsylvania, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
York, Pennsylvania, United States
Providence, Rhode Island, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Sherman, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Johnson WB, Abraham WT, Young JB, Wheelan K, Smith AL, Chang Y, Brinkman P; InSync Registry Investigators. Long-term performance of the attain model 4193 left ventricular lead. Pacing Clin Electrophysiol. 2009 Sep;32(9):1111-6. doi: 10.1111/j.1540-8159.2009.02451.x.
Other Identifiers
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187
Identifier Type: -
Identifier Source: org_study_id
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