Attain Model 4196 Left Ventricular (LV) Lead
- Conditions
- Heart Failure
- Interventions
- Device: Pacing Lead
- Registration Number
- NCT00271544
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 4196 Lead Pacing Lead Non-randomized study.
- Primary Outcome Measures
Name Time Method Safety (Subjects Without a Model 4196 Lead Related Complication) 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) 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) Three Months Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
- Secondary Outcome Measures
Name Time Method Subjects Successfully Implanted With Model 4196 Lead Implant A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.
Subjects Successfully Implanted After Cannulation Implant A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.
All Left Ventricular Leads Implant All left ventricular leads successfully implanted
All Medtronic Left Ventricular Leads (Attain Family) Implant All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted
Cannulation Time Implant Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.
Fluoroscopy Time Implant Fluoroscopy time was defined as the total time the fluoroscope was imaging.
Model 4196 Lead Placement Time Implant Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.
Total Implant Time Implant Total implant time was defined as time from initial incision to final closure.
Assessment of Lead Handling Characteristics Implant Lead handling characteristics assessed as "acceptable" by physicians
Electrical Performance - Tip Electrode: Sensing 12-month Model 4196 lead tip electrode R-wave amplitude
Electrical Performance - Tip Electrode: LV Voltage Threshold 12-month Model 4196 lead tip electrode LV voltage threshold
Electrical Performance -Tip Electrode: Pacing Impedance 12-month Model 4196 lead tip electrode pacing impedance
Electrical Performance -Ring Electrode: Sensing Implant Model 4196 lead ring electrode R-wave amplitude
Electrical Performance - Ring Electrode: LV Voltage Threshold 12-month Model 4196 lead ring electrode LV voltage threshold
Electrical Performance -Ring Electrode: Pacing Impedance 12-Month Model 4196 lead ring electrode pacing impedance
Summarize All Adverse Events Up to 18 months All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu