Attain Model 4196 Left Ventricular (LV) Lead

Study Overview
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Brief Summary
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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).

Official Title
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Attain Model 4196 Left Ventricular (LV) Lead

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Pacing Lead


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4196 Lead<br>Non-randomized study. | Device: Pacing Lead<br>* implant and follow-up of study device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Subjects Without a Model 4196 Lead Related Complication) | A subject who was free of a Model 4196 lead related complication by one month visit. | One Month | 
| Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) | Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms]) | One Month | 
| Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) | Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms]) | Three Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Successfully Implanted With Model 4196 Lead | A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately. | Implant | 
| Subjects Successfully Implanted After Cannulation | 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. | Implant | 
| All Left Ventricular Leads | All left ventricular leads successfully implanted | Implant | 
| All Medtronic Left Ventricular Leads (Attain Family) | All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted | Implant | 
| Cannulation Time | Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation. | Implant | 
| Fluoroscopy Time | Fluoroscopy time was defined as the total time the fluoroscope was imaging. | Implant | 
| Model 4196 Lead Placement Time | 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. | Implant | 
| Total Implant Time | Total implant time was defined as time from initial incision to final closure. | Implant | 
| Assessment of Lead Handling Characteristics | Lead handling characteristics assessed as acceptable by physicians | Implant | 
| Electrical Performance - Tip Electrode: Sensing | Model 4196 lead tip electrode R-wave amplitude | 12-month | 
| Electrical Performance - Tip Electrode: LV Voltage Threshold | Model 4196 lead tip electrode LV voltage threshold | 12-month | 
| Electrical Performance -Tip Electrode: Pacing Impedance | Model 4196 lead tip electrode pacing impedance | 12-month | 
| Electrical Performance -Ring Electrode: Sensing | Model 4196 lead ring electrode R-wave amplitude | Implant | 
| Electrical Performance - Ring Electrode: LV Voltage Threshold | Model 4196 lead ring electrode LV voltage threshold | 12-month | 
| Electrical Performance -Ring Electrode: Pacing Impedance | Model 4196 lead ring electrode pacing impedance | 12-Month | 
| Summarize All Adverse Events | All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu | Up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cardiac pacing, left ventricular lead, cardiac resynchronization therapy