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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe survival rate
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).
Time frame: 30 days after device explant, or hospital discharge (whichever is longer), or to the induction of anesthesia to a longer-term therapy
Death
All-cause death
Time frame: 30 days after device explant, 90 days after device explant
Major Bleeding
MCS-ARC 3, 4, 5 type bleeding
Time frame: 30 days after device explant
Major hemolysis
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
Time frame: 30 days after device explant
Pulmonary embolism
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.
Time frame: 30 days after device explant
Tricuspid and/or pulmonary valve dysfunction
Tricuspid and/or pulmonic increase in valve regurgitation by more than one assessment level as determined by echocardiographic measurement vs baseline.
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Time frame: 30 days after device explant
MACCE
Major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke.
Time frame: 30 days after device explant, 90 days after device explant
Changes in CVP
Changes in central venous pressure (CVP) after CorVad support (compared to baseline), measured by central venous catheter or right heart catheter
Time frame: 24 hours after CorVad support
Changes in CI
Changes in cardiac index (CI) after CorVad support (compared to baseline), measured by right heart catheter or echocardiography
Time frame: 24 hours after CorVad support
Changes in LVAD flow
Changes in LVAD flow (if applicable) compared to baseline
Time frame: within 48 hours after CorVad support
Decreased use of inotropes/vasopressor during support
Time frame: during CorVad support, after 30 days post explant and after 90 days post explant