Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic
The purpose of this study is to evaluate long-term performance of the 4296 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 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive an Attain Ability Model 4296 LV lead
Patient within 30 day post implant enrollment window
You may not be if
Patient who is, or is expected to be inaccessible for follow-up
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
