Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring 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 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.
Condition or disease
Model 4195 LV lead complication-free survivability will be summarized.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients implanted with a 4195 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.
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 StarFix Model 4195 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