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New treatment option for Refractory Heart Failure
Official title Corheart 6 LVAS Study
ClinicalTrials.gov ID: NCT05876000
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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%
You likely can't join if
- 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...
- 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 compliance with the study...
- 6\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
See the full eligibility criteria
Who can join
- 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,
- 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 \>...
- c. Impella or IABP assisted;
- d. Inotrope dependent/unable to wean from inotropes.
What rules you out
- 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 compliance with the study protocol and ventricular assist system management.
- 6\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- 7\. Presence of an active, uncontrolled infection.
- 8\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- a. Total bilirubin \> 51.3 μmol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.
- b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, or FEV1 \< 50% predicted.
- c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
- d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\> 70%) carotid artery stenosis
- e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
- f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
- 9\. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
- 10\. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
- 11\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
- 12\. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
- 13\. STEMI \<2 weeks before planned implantation.
- 14\. Right ventricular failure as defined by one or more of the following:
- a. severe depressed RV function in echocardiography
- b. TAPSE \< 1.0 cm
- c. CVP/PCWP ratio \> 0.63
- 15\. Planned Bi-VAD support prior to enrollment.
- 16\. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
- 17\. History of any organ transplant.
- 18\. Pre albumin \< 150 mg/L, or Albumin \< 30g/L (3 g/dL).
- 19\. Any condition other than HF that could limit survival to less than 24 months.
- 20\. Positive pregnancy test if of childbearing potential.
- 21\. Lactating mothers.
- 22\. Participation in any other clinical investigation that is likely to confound study results or affect the study.
- 23\. Patients who have been placed in an institution by court order or by order of the authorities.
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Vienna, Austria
- Bad Oeynhausen, Germany
- Berlin, Germany
- Bremen, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Leipzig, Germany
- Würzburg, Germany
- Milan, Italy
- Torino, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Vienna, Austria; Bad Oeynhausen, Germany; Berlin, Germany; Bremen, Germany; Hamburg, Germany and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.