Attain Model 4196 Left Ventricular (LV) Lead
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 190
- Primary Endpoint
- Safety (Subjects Without a Model 4196 Lead Related Complication)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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 (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).
Investigators
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)
Outcomes
Primary Outcomes
Safety (Subjects Without a Model 4196 Lead Related Complication)
Time Frame: One Month
A subject who was free of a Model 4196 lead related complication by one month visit.
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
Time Frame: One Month
Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
Time Frame: Three Months
Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
Secondary Outcomes
- Subjects Successfully Implanted With Model 4196 Lead(Implant)
- Subjects Successfully Implanted After Cannulation(Implant)
- All Left Ventricular Leads(Implant)
- All Medtronic Left Ventricular Leads (Attain Family)(Implant)
- Cannulation Time(Implant)
- Fluoroscopy Time(Implant)
- Model 4196 Lead Placement Time(Implant)
- Total Implant Time(Implant)
- Assessment of Lead Handling Characteristics(Implant)
- Electrical Performance - Tip Electrode: Sensing(12-month)
- Electrical Performance - Tip Electrode: LV Voltage Threshold(12-month)
- Electrical Performance -Tip Electrode: Pacing Impedance(12-month)
- Electrical Performance -Ring Electrode: Sensing(Implant)
- Electrical Performance - Ring Electrode: LV Voltage Threshold(12-month)
- Electrical Performance -Ring Electrode: Pacing Impedance(12-Month)
- Summarize All Adverse Events(Up to 18 months)