NCT05727059

Magenta Elevate™ EFS in High-Risk PCI Patients

Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Magenta Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Detailed description

The Elevate™ EFS is planned as a prospective, single-arm, interventional multi-center study enrolling up to 20 subjects. The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta. The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

Conditions

• High-risk Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	The Elevate™ System	The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-12-01
• Completion: 2024-01-02
• First posted: 2023-02-14
• Last updated: 2024-09-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study