Heart Failure
Conditions
Brief summary
The purpose of this study is to evaluate long-term performance of the 4196 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).
Detailed description
Model 4196 LV lead complication-free survivability will be summarized.
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients who meet all of the following inclusion criteria and do not meet any of the following
Exclusion criteria
are eligible for enrollment. Inclusion Criteria * 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 4196 LV lead * Patient within 30 day post implant enrollment window
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lead-related complication rate | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Types of lead-related events | 5 years |
| Percent of subjects with changes in electrode programming | 5 Years |
| Percent of fractures with loss of function | 5 years |
| Mean bipolar pacing threshold | 1 year |
| Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations | 1 year |
Countries
Austria, Belgium, Canada, France, Italy, Netherlands, Spain, United States
Outcome results
None listed