Heart Failure Clinical Trial

Attain StarFixâ„¢ Model 4195 Left Ventricular Lead

Summary

People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The device may also be able to stop the heart from beating too fast. Three leads are implanted into the chambers of your heart. Two of the leads will be placed on the right side of your heart. The third lead is placed on the left side of your heart and is the lead being studied.

The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

QRS > 130 ms (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) < 35% (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)

Study is for people with:

Heart Failure

Estimated Enrollment:

441

Study ID:

NCT00269230

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There is 1 Location for this study

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Long Beach California, , United States

Palo Alto California, , United States

Newark Delaware, , United States

Jacksonville Florida, , United States

Orlando Florida, , United States

Atlanta Georgia, , United States

Lexington Kentucky, , United States

Grand Rapids Michigan, , United States

Saginaw Michigan, , United States

St. Paul Minnesota, , United States

St. Louis Missouri, , United States

Lincoln Nebraska, , United States

Newark New Jersey, , United States

Rochester New York, , United States

Durham North Carolina, , United States

Germantown Tennessee, , United States

Nashville Tennessee, , United States

Dallas Texas, , United States

Temple Texas, , United States

Milwaukee Wisconsin, , United States

Calgary Alberta, , Canada

Victoria British Columbia, , Canada

London Ontario, , Canada

Sainte-Foy Quebec, , Canada

Milano , , Italy

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

441

Study ID:

NCT00269230

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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