Heart Failure Clinical Trial
InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
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).
Full Description
Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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There is 1 Location for this study
Birmingham Alabama, , United States
Peoria Arizona, , United States
Ft. 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
Springfield Missouri, , United States
St. Joseph 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
Ft. 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
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