clinical trial · NCT04024943
Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Medtronic·—·active not recruiting·n = 1,092
Heart FailureQuadripolar LV Lead
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).
started
Aug 21, 2017
primary completion
Jul 1, 2027
completion
Jan 1, 2028
last updated
Feb 4, 2026
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol