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RECRUITING
NCT05876000
NA

Corheart 6 LVAS Study

Sponsor: Shenzhen Core Medical Technology CO.,LTD.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2024-05-14

Completion Date

2031-06-30

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DEVICE

Corheart 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