RecruitingNot ApplicableNCT06907017

CorWave LVAS FIH Study

First In Human Clinical Study of the CorWave Left Ventricular Assist System for the Treatment of Patients With Advanced Heart Failure

Sponsor

CorWave

Enrollment

20 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Heart Failure

Summary

The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of mechanical heart pump (called the CorWave LVAS) in patients with severe heart failure who depend on medications or other devices to keep their heart going, to see if it is safe and works as a bridge to a heart transplant. **You may be eligible if...** - You are between 18 and 75 years old - You have a very weak heart (ejection fraction of 35% or less) - You depend on IV medications to support your heart, or your heart cannot pump enough blood even without those medications - You are on the waiting list or eligible for a heart transplant - Women of childbearing age must agree to use contraception **You may NOT be eligible if...** - Your heart failure is caused by a condition that makes implanting the device unsafe - You are not eligible for heart transplantation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELVAS

Implantation and use of the CorWave LVAS to evaluate the safety and effectiveness of the CorWave LVAD to treat advanced left ventricular heart failure.