Heart Failure
Conditions
Brief summary
Lead survivability will be summarized.
Detailed description
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.
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 4396 LV lead * Patient within 30 day post implant enrollment window
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Model 4396 LV Lead-related complication rate | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Percent of subjects with changes in electrode programming | 5 years |
| Number of fractures with and without loss of function | 5 years |
| Types of lead-related adverse device effects | 5 years |
| Bipolar pacing impedance | 1 year |
| Bipolar pacing capture threshold | 1 year |
| Bipolar electrical performance at 1 year | 1 year |
Countries
Canada, Germany, United States
Outcome results
None listed