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 Attain Performa™ LV Leads. 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 Attain Performa™ LV Leads. 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 Performa™ LV lead * Patient within 30 day post implant enrollment window
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lead complication | 5 years | Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study. Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Types of lead-related adverse device effects | 5 years | Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure. |
| Returned lead analysis | 5 years | A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported. |
| Lead survival estimate by model | 5 years | An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model. |
Countries
Belgium, Canada, France, Germany, Netherlands, Switzerland, United Kingdom, United States
Outcome results
None listed