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Clinical Trial Summary

The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.


Clinical Trial Description

The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients. The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease. 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. ;


Study Design


Related Conditions & MeSH terms

  • High-Risk Percutaneous Coronary Intervention

NCT number NCT06099548
Study type Interventional
Source Magenta Medical Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date December 17, 2020
Completion date March 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04477603 - Impella ECP Early Feasibility Study N/A
Recruiting NCT06132568 - VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS) N/A
Recruiting NCT05727059 - Magenta Elevate™ EFS in High-Risk PCI Patients N/A
Recruiting NCT04321148 - Protect Kidney Trial N/A
Enrolling by invitation NCT05334784 - Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol N/A