InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry

NCT00273182 | Completed Results

• 1 other identifier: 187
• Study Type: observational
• Target: 1,999
• Locations: 1 country
• Sites: 82

Brief Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. 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).

Conditions

Heart Failure; Cardiomyopathy

Keywords

Heart Failure; Cardiomyopathy; Cardiac pacing; Cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.

  Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules

  36 month follow-up

Secondary Outcomes (4)

• Left Ventricular (LV) Lead R-wave Amplitude

  36 month follow-up

• Left Ventricular (LV) Lead Impedance

  36 months follow-up

• Left Ventricular (LV) Lead Pacing Voltage Threshold

  36 months follow-up

• Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant

  36 months follow-up

Study Arms (1)

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.

Device: InSync Model 8040; Device: InSync III Model 8042

Interventions

InSync Model 8040 DEVICE

Subjects with sucessful implants of InSync Model 8040.

Cohort

InSync III Model 8042 DEVICE

Subjects with successful implants of InSync III Model 8042

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for use of a cardiac device

You may qualify if:

• Patients implanted with an InSync Model 8040 or InSync III Model 8042, a right ventricular lead, and a Medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy.

You may not qualify if:

• Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync Registry

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (82)

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Birmingham, Alabama, United States

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Peoria, Arizona, United States

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Fort Smith, Arkansas, United States

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Little Rock, Arkansas, United States

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Long Beach, California, United States

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Napa, California, United States

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Oxnard, California, United States

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San Diego, California, United States

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Yuba City, California, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Salisbury, Maryland, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Worchester, Massachusetts, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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Lansing, Michigan, United States

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Marquette, Michigan, United States

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Saginaw, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Hattiesburg, Mississippi, United States

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Tupelo, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Saint Joseph, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Lincoln, Nebraska, United States

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Newark, New Jersey, United States

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Manhasset, New York, 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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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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High Pointe, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, 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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Mayfield Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Doylestown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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York, Pennsylvania, United States

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Providence, Rhode Island, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Sherman, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Related Publications (1)

• 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.

  PMID: 19719485 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: InSync Registry Clinical Trial Leader
• Organization: Medtronic, Inc.

medtroniccrmtrials@medtronic.com

Study Officials

• InSync Registry Study Leader

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 9, 2006
• Study Start: March 1, 2002
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 5, 2013
• Results First Posted: August 5, 2013

Record last verified: 2013-07

Locations

US (82)