InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
1 other identifier
observational
600
1 country
51
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. 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 ICD device can change the timing of when the left and right ventricles of the heart are paced to beat. The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2003
Longer than P75 for all trials
51 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
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 5, 2007
September 1, 2006
February 7, 2006
October 3, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients implanted with the InSync ICD or InSync Marquis cardiac resynchronization therapy (CRT) system (includes InSync ICD Model 7272 or InSync Marquis Model 7277, right atrial lead, right ventricular lead and any market released Medtronic left ventricular lead or the investigational Attain Model 4189 lead which was implanted during the MIRACLE ICD Study)
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 ICD Registry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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San Diego, California, United States
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Stanford, California, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Oak Lawn, Illinois, United States
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Indianapolis, Indiana, United States
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Davenport, Iowa, United States
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Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Houma, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Hackensack, New Jersey, United States
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Albany, New York, United States
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Chapel Hill, North Carolina, 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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Mayfield Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Erie, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Providence, Rhode Island, United States
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Spartanburg, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, 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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Seattle, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
InSync ICD Registry Study Leader
Medtronic
Study Design
- Study Type
- observational
- Observational Model
- DEFINED POPULATION
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 9, 2006
Study Start
January 1, 2003
Study Completion
December 1, 2006
Last Updated
October 5, 2007
Record last verified: 2006-09