NCT03099655

Attain Stability™ Quad Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).

Detailed description

The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, investigational Device Exemption (IDE), interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary efficacy endpoints. All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798). Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Attain Stability Quad Left Ventricular Pacing Lead	cardiac stimulation

Timeline

• Start date: 2017-07-07
• Primary completion: 2018-08-02
• Completion: 2019-05-31
• First posted: 2017-04-04
• Last updated: 2020-01-09
• Results posted: 2020-01-09

Locations

50 sites across 10 countries: United States, Canada, Germany, Hong Kong, Italy, Malaysia, Netherlands, Norway, Spain, Sweden

Regulatory

• FDA-regulated device study