Attain Model 4196 Left Ventricular (LV) Lead

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Pacing Lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT00271544

241

Details and patient eligibility

About

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).

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

4196 Lead

Experimental group

Description:

Non-randomized study.

Treatment:

Device: Pacing Lead