NCT04024943

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,092 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-21
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2019-07-18
• Last updated: 2026-02-04

Locations

115 sites across 9 countries: United States, France, Greece, Italy, Portugal, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study