Model 4396 Left Ventricular (LV) Lead Study

Study Overview
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Brief Summary
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This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Detailed Description
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This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.

Official Title
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Model 4396 Left Ventricular Lead Study

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: CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable Exclusion Criteria: LV lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for transvenous pacing, heart transplant

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Model 4396 LV 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 4396 Lead Related Complication) | A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids). | One month | 
| Efficacy: Distal Tip Electrode Voltage Threshold | Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds [ms]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle. | One month | 
| Efficacy: Proximal Ring Voltage Threshold | Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Successfully Implanted With Model 4396 Lead | A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body. | During implant procedure. | 
| Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation | A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body. | During implant procedure. | 
| Subjects Successfully Implanted With Any Transvenous LV Lead | A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately. | During implant procedure. | 
| Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead | A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396. | During implant procedure. | 
| Cannulation Time | Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation. | During implant procedure. | 
| Fluoroscopy Time | The total time the fluoroscope was imaging (not including biplane fluoroscopy time). | During implant procedure. | 
| Model 4396 Lead Placement Time | Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location. | During implant procedure. | 
| Total Operation Time | Total operation time was defined as time from initial incision to final closure. | During implant procedure. | 
| Assessment of Lead Handling Characteristics Reported as Acceptable | Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized. | During implant procedure. | 
| Efficacy: Bipolar Voltage Threshold | Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts. | 1 month | 
| Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold | Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized. | 6 month | 
| Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance | Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here. | 6 month | 
| Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing | Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense. | 6 month | 
| Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold | Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here. | 6 month | 
| Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance | Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here. | 6 month | 
| Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing | Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements. | During implant procedure. | 
| Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold | Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here. | 6 month | 
| Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance | Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here. | 6 month | 
| Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing | Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. | 6 month | 

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