Lead survivability will be summarized.
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
Study Type
OBSERVATIONAL
Enrollment
366
Model 4396 LV Lead-related complication rate
Time frame: 5 years
Types of lead-related adverse device effects
Time frame: 5 years
Percent of subjects with changes in electrode programming
Time frame: 5 years
Number of fractures with and without loss of function
Time frame: 5 years
Bipolar electrical performance at 1 year
Time frame: 1 year
Bipolar pacing impedance
Time frame: 1 year
Bipolar pacing capture threshold
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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