Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Quadripolar LV Lead


Participation Criteria
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Eligibility Criteria
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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 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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Quadripolar 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients without a lead- related event at 5 years post-implant | To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lead-related adverse device effects | 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 | 5 years | 
| Number of explanted leads that have been returned | 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 | 5 years |