Right Heart Failure
Conditions
Keywords
Right heart failure, pVAD, CorVad
Brief summary
The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic instability despite best medical therapy.
Interventions
The CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) is used to provide hemodynamic support by shareing some or all the workload of the right ventricles during the support period.
Sponsors
Shenzhen Core Medical Technology CO.,LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
CorVad Percutaneous Ventricular Assist System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who develop refractory right heart failure within 48 hours after left ventricular assist device (LVAD) implantation, myocardial infarction, heart transplantation, or open-heart surgery, defined as: * despite ongoing treatment with oral heart failure medications, including continuous infusion of high-dose inotropic agents and/or vasopressors, and/or the use of more than one inotropic agent and/or vasopressor, the cardiac index (CI) remains less than 2.2 L/min/m²; * and meets any one of the following criteria: 1) CVP \> 15 mmHg; or, 2) CVP/pulmonary capillary wedge pressure (PCWP) or CVP/left atrial pressure (LAP) \> 0.63; or, 3) echocardiographic evidence of moderate-to-severe right ventricular dysfunction meeting one of the following criteria: right ventricular basal diameter \> 42 mm, right ventricular short-axis (or mid-chamber) diameter \> 35 mm, tricuspid annular systolic excursion (TAPSE) score \< 14 mm, right ventricular fractional area change (FAC) \< 30%, tricuspid annular systolic peak velocity (TDI S') \< 9 cm/s, and right ventricular free wall longitudinal strain \> -20%. 2. ≥ 18 years old. 3. The patient or the patient's legal representative agrees to sign the informed consent form.
Exclusion criteria
1. INTERMACS Stage 1 is defined as: despite the use of inotropic agents (positive inotropic drugs) and/or temporary mechanical support (such as IABP or ECMO), the patient remains hypotensive and shows signs of inadequate perfusion of vital organs (such as oliguria or worsening liver function), requiring immediate initiation of mechanical circulatory support to survive. 2. Severe hepatic or renal dysfunction, defined as total bilirubin ≥ 5 mg/dL or creatinine ≥ 4 mg/dL within 24 hours prior to treatment with the investigational device. 3. For patients who have undergone LVAD implantation, acute neurological injury occurring after implantation, including stroke, hypoxic encephalopathy, or acute neurological deficits (such as seizures or altered levels of consciousness). 4. Acute myocardial infarction with mechanical complications, including ventricular septal defect, cardiac rupture, or papillary muscle rupture. 5. Failed revascularization (for patients requiring right coronary revascularization), defined as a TIMI blood flow grade of 0 or 1 following percutaneous coronary intervention or coronary artery bypass grafting. 6. Active infection, meeting at least two of the following criteria: white blood cell count \> 12,500/μL, positive blood culture, or fever. 7. Thrombus in the right atrium, right ventricle, and/or pulmonary artery. 8. History of mechanical valve replacement of the tricuspid or pulmonary valve. 9. Severe tricuspid stenosis or regurgitation. 10. Severe pulmonary valve stenosis or regurgitation. 11. Severe pulmonary hypertension, defined as a pulmonary artery systolic pressure \> 60 mmHg. 12. Current diagnosis of pulmonary embolism. 13. History of pulmonary artery graft replacement (artificial vessel). 14. Current use of a right heart assist device or extracorporeal membrane oxygenation (ECMO) device. 15. Thrombosis of the internal jugular vein and deep veins of the lower extremities, and/or the presence of a vena cava filter. 16. Anatomical conditions that interfere with pump implantation or the safe use of the device, such as aortic dissection, Marfan syndrome, Erdheim-Chirlow disease (i.e., idiopathic medial necrosis, commonly associated with aortic dissection), etc. 17. Congenital heart disease that precludes device implantation, or an unrepairated atrial septal defect or patent foramen ovale. 18. Allergy or intolerance to contrast agents, or intolerance to anticoagulant or antiplatelet therapy. 19. History of thrombolytic therapy within the past 30 days, known coagulation disorders, or hematologic disorders causing blood cell fragility or hemolysis. 20. Female patients who are pregnant or breastfeeding. 21. Participation in any other clinical trial that may confound the study results or affect the study outcomes. 22. Other circumstances deemed by the investigator to be incompatible with inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The survival rate | 30 days after device explant, or hospital discharge (whichever is longer), or to the induction of anesthesia to a longer-term therapy | Feasibility endpoint at 30 days after device explant or at hospital discharge (whichever is longer) or to the induction of anesthesia to a longer-term therapy, which includes a heart transplant or an implant of a surgical right ventricular assist device (RVAD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 30 days after device explant, 90 days after device explant | All-cause death |
| Major Bleeding | 30 days after device explant | MCS-ARC 3, 4, 5 type bleeding |
| Major hemolysis | 30 days after device explant | Two plasma-free Hgb values \> 40mg/dl with the 2 readings taken within a single 48-hour period. If plasma-free Hgb not available, hemolysis will be defined by the combination of clinical signs (see below) and laboratory testing including increased LDH, increased bilirubin and decreased hemoglobin (all 3 required). It requires the presence of one or more of the following conditions: 1. Hemoglobinuria 2. Anemia 3. Hyperbilirubinemia 4. Pumpmalfunctionand/orabnormalpumpparameters |
| Pulmonary embolism | 30 days after device explant | New presence of blockage in the pulmonary artery caused by a clot and documented clinically and confirmed by computed tomography scan, magnetic resonance imaging, or pulmonary angiography. |
| Tricuspid and/or pulmonary valve dysfunction | 30 days after device explant | Tricuspid and/or pulmonic increase in valve regurgitation by more than one assessment level as determined by echocardiographic measurement vs baseline. |
| MACCE | 30 days after device explant, 90 days after device explant | Major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. |
| Changes in CVP | 24 hours after CorVad support | Changes in central venous pressure (CVP) after CorVad support (compared to baseline), measured by central venous catheter or right heart catheter |
| Changes in CI | 24 hours after CorVad support | Changes in cardiac index (CI) after CorVad support (compared to baseline), measured by right heart catheter or echocardiography |
| Changes in LVAD flow | within 48 hours after CorVad support | Changes in LVAD flow (if applicable) compared to baseline |
| Decreased use of inotropes/vasopressor during support | during CorVad support, after 30 days post explant and after 90 days post explant | — |
Countries
China
Contacts
CONTACTXiaoli Shi
Outcome results
None listed