Corheart 6 LVAS Study (NCT05876000) | Clinical Trial Compass
RecruitingNot Applicable
Corheart 6 LVAS Study
Austria, Germany53 participantsStarted 2024-05-14
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age ≥ 18 years and ≤ 75 years
* 2\. The patient has signed an Informed Consent Form
* 3\. Body Surface Area (BSA) ≥ 1.2 m\^2
* 4\. New York Heart Association (NYHA) Class IV
* 5\. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
* 6\. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
* a. Unable to exercise for HF,
* or
* if able to perform cardiopulmonary testing, with peak VO2 \<12 mL/kg/min and/or \< 50% predicted value;
* b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP \> 20 mmHg and SBP \< 90 mmHg or CI \< 2.0 L/min/m2).
* c. Impella or IABP assisted;
* d. Inotrope dependent/unable to wean from inotropes.
Exclusion Criteria:
* 1\. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
* 2\. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
* 3\. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
* 4\. Platelet count \< 100,000 x 10\^3/L (\< 100,000/ml).
* 5\. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair…