RecruitingNot ApplicableNCT05876000

Corheart 6 LVAS Study

Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System


Sponsor

Shenzhen Core Medical Technology CO.,LTD.

Enrollment

53 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation. The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of a new mechanical heart pump (called Corheart 6) in patients with very severe heart failure whose heart cannot pump enough blood on its own. This type of device — called a ventricular assist device (VAD) — helps the heart do its job and may be a bridge to a heart transplant or long-term support. **You may be eligible if...** - You are between 18 and 75 years old - You have severe heart failure (NYHA Class IV — unable to do any activity without symptoms) - Your heart pumping function is 25% or less (ejection fraction) - Despite the best available medications, you still have severe symptoms such as inability to exercise, organ dysfunction, or dependence on intravenous heart medications or a temporary mechanical support device **You may NOT be eligible if...** - Your heart failure can be treated with other devices like a pacemaker - You have serious bleeding or clotting disorders - You have severe liver, lung, kidney disease, or recent stroke - You have an active infection - You are pregnant or breastfeeding - You had a heart attack within the past 2 weeks - You have severe right-sided heart failure or have had an organ transplant 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.

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Interventions

DEVICECorheart 6 Left Ventricular Assist System

Implantation of left ventricular assist device for mechanical circulatory support


Locations(11)

Universitätsklinikum Graz

Graz, Austria

Universitätskliniken der MedUni Wien

Vienna, Austria

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

Deutsches Herzzentrum der Charité

Berlin, Germany

Klinikum Links der Weser

Bremen, Germany

Universitätsklinikum Hamburg

Hamburg, Germany

Universitätsklinikums Heidelberg

Heidelberg, Germany

Herzzentrum Leipzig

Leipzig, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, Italy

View Full Details on ClinicalTrials.gov

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NCT05876000


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