A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)

Heart Failure Clinical Trial

Official title: Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure

Status Active, not recruiting

Clinical Trial Summary

This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure

Clinical Trial Description

This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT01831544
• Study type: Interventional
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2015
• Completion date: December 2022