Actively Recruiting
Corheart 6 LVAS Study
Led by Shenzhen Core Medical Technology CO.,LTD. · Updated on 2026-01-08
53
Participants Needed
11
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Corheart 6 LVAS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 75 years or younger
- Signed informed consent form
- Body Surface Area (BSA) of 1.2 m2 or greater
- New York Heart Association (NYHA) Class IV heart failure
- Left Ventricular Ejection Fraction (LVEF) of 25% or less
- Despite optimal medical treatment, patients must have one or more of the following: unable to exercise for heart failure, or if able, peak VO2 less than 12 mL/kg/min or less than 50% predicted; progressive end-organ dysfunction due to reduced perfusion; use of Impella or IABP devices; or inotrope dependence or inability to wean from inotropes
You will not qualify if you...
- Heart failure treatable with other therapies like CRT or CRT-D
- Intolerance to anticoagulant, antiplatelet, or other required therapies
- Known hypo- or hypercoagulable states such as disseminated intravascular coagulation or heparin-induced thrombocytopenia type II
- Platelet count less than 100,000/ml
- Psychiatric disorders, irreversible cognitive dysfunction, or psychosocial issues impairing compliance
- Technical obstacles posing high surgical risk
- Active, uncontrolled infection
- Severe end-organ dysfunction or failure risk factors including: high bilirubin, ischemic hepatitis, liver cirrhosis, severe COPD, fixed pulmonary hypertension unresponsive to treatment, recent stroke or significant carotid artery disease, severe kidney dysfunction or dialysis, significant peripheral vascular disease
- Heart failure due to uncorrected thyroid disease, certain cardiomyopathies, pericardial disease, amyloidosis, or giant cell myocarditis
- Uncorrected moderate to severe aortic insufficiency without plans for correction during implant
- History of untreated large abdominal or thoracic aortic aneurysm
- Uncontrollable ventricular arrhythmias
- Recent STEMI within 2 weeks before implantation
- Right ventricular failure defined by specific echocardiographic and hemodynamic criteria
- Planned Bi-VAD support before enrollment
- Recent cardiac arrest without full cognitive recovery
- History of organ transplant
- Low pre-albumin or albumin levels
- Any condition other than heart failure limiting survival to less than 24 months
- Positive pregnancy test if of childbearing potential
- Lactating mothers
- Participation in other conflicting clinical trials
- Placement in an institution by court or authorities order
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Universitätsklinikum Graz
Graz, Austria
Not Yet Recruiting
2
Universitätskliniken der MedUni Wien
Vienna, Austria
Actively Recruiting
3
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Actively Recruiting
4
Deutsches Herzzentrum der Charité
Berlin, Germany
Actively Recruiting
5
Klinikum Links der Weser
Bremen, Germany
Not Yet Recruiting
6
Universitätsklinikum Hamburg
Hamburg, Germany
Actively Recruiting
7
Universitätsklinikums Heidelberg
Heidelberg, Germany
Actively Recruiting
8
Herzzentrum Leipzig
Leipzig, Germany
Actively Recruiting
9
Universitätsklinikum Würzburg
Würzburg, Germany
Not Yet Recruiting
10
IRCCS Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
11
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Not Yet Recruiting
Research Team
X
Xiaoli Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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