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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CorVad Percutaneous Ventricular Assist System | Experimental | Device model: CorVad RS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorVad Percutaneous Ventricular Assist System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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). | 30 days after device explant, or hospital discharge (whichever is longer), or to the induction of anesthesia to a longer-term therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Death | All-cause death | 30 days after device explant, 90 days after device explant |
| Major Bleeding | MCS-ARC 3, 4, 5 type bleeding | 30 days after device explant |
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Inclusion Criteria:
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:
≥ 18 years old.
The patient or the patient's legal representative agrees to sign the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Shi | Contact | +86 13418601356 | shixiaoli@coretechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230022 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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CorVad Percutaneous Ventricular Assist System
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| 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:
| 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. | 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. | 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. | 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 | 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 | 24 hours after CorVad support |
| Changes in LVAD flow | Changes in LVAD flow (if applicable) compared to baseline | within 48 hours after CorVad support |
| Decreased use of inotropes/vasopressor during support | during CorVad support, after 30 days post explant and after 90 days post explant |
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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