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).
Protocol Amendment History
10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-07-17; most recent amendment 2026-02-02.
Status change: Recruiting → Active, Not Recruiting2023-12-04