Heart Failure Clinical Trial
Attain Model 4196 Left Ventricular (LV) Lead
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 (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
Eligibility Criteria
Inclusion Criteria:
QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
Subject has moderate to severe heart failure despite medications
Exclusion Criteria:
Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
Subjects that have had certain surgeries on their heart within the past three months
Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)
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There is 1 Location for this study
Anchorage Alaska, , United States
Phoenix Arizona, , United States
Long Beach California, , United States
Palo Alto California, , United States
Davenport Iowa, , United States
Lexington Kentucky, , United States
Baton Rouge Louisiana, , United States
Detroit Michigan, , United States
Minneapolis Minnesota, , United States
Kansas City Missouri, , United States
Raleigh North Carolina, , United States
Mayfield Heights Ohio, , United States
Wynnewood Pennsylvania, , United States
Spartanburg South Carolina, , United States
Kingsport Tennessee, , United States
Memphis Tennessee, , United States
Dallas Texas, , United States
Fort Worth Texas, , United States
Burlington Vermont, , United States
Calgary Alberta, , Canada
Edmonton Alberta, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Sainte-Foy Quebec, , Canada
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