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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
197
implant and follow-up of study device
Unnamed facility
Pasadena, California, United States
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).
Time frame: 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.
Time frame: 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.
Time frame: Three months
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.
Time frame: During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
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Unnamed facility
Sacramento, California, United States
Unnamed facility
Atlantis, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Hinsdale, Illinois, United States
Unnamed facility
Davenport, Iowa, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Baton Rouge, Louisiana, United States
Unnamed facility
Saint Louis Park, Minnesota, United States
...and 21 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During implant procedure.
Fluoroscopy Time
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Time frame: 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.
Time frame: During implant procedure.
Total Operation Time
Total operation time was defined as time from initial incision to final closure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 month