Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Personalized Therapy Study - Attain Stability Quad Post-Approval Study
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).
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.
Inclusion Criteria:
Exclusion Criteria:
New York, New York 10032, United States
Akron, Ohio 44304-1473, United States
Birmingham, United Kingdom
Blackpool, United Kingdom