Attain Ability® Family Left Ventricular Lead Chronic Performance Study
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.
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
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 4396 LV lead
Patient within 30 day post implant enrollment window
Patient who is, or is expected to be inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
University of California San Francisco UCSF Medical Center San Francisco, California, 94143, USA
Eisenhower Desert Cardiology Center Rancho Mirage, California, 92270, USA
Redding Heart Care Redding, California, 96001, USA
South Bay Electrophysiology Torrance, California, 90503, USA
Cardiovascular Consultants Medical Group Van Nuys, California, 91405, USA