Heart Failure
Conditions
Brief summary
The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).
Detailed description
The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.
Interventions
DEVICEQuadripolar LV Lead
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is an active fixation quadripolar LV lead based on the Attain Performa lead family models (4298, 4398, and 4598). The lead incorporates an active fixation helix similar to the OUS commercialized Attain Stability bipolar LV lead (Model 20066/4796) which is designed to allow an implanter more options in lead location.
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 or be treated with a Model 4798 lead and a Medtronic CRT device * Patient within 30 days of therapy received at the time of their initial PSR platform enrollment
Exclusion criteria
* Patient who is, or is expected to be inaccessible for follow-up * Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients without a lead- related event at 5 years post-implant | 5 years | To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of lead-related adverse device effects | 5 years | The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product: • To summarize all Attain Stability Quad lead-related ADEs |
| Number of explanted leads that have been returned | 5 years | The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product: • To summarize analysis results from explanted and returned Attain Stability Quad leads |
Countries
France, Greece, Italy, Portugal, Slovakia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed