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Tests treatment safety and results for Right Heart Failure
Official title Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure
ClinicalTrials.gov ID: NCT07704424
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who develop refractory right heart failure within 48 hours after left ventricular assist device (LVAD) implantation, myocardial infarction...
- despite ongoing treatment with oral heart failure medications, including continuous infusion of high-dose inotropic agents and/or vasopressors...
- 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...
- ≥ 18 years old.
- The patient or the patient's legal representative agrees to sign the informed consent form.
You likely can't join if
- INTERMACS Stage 1 is defined as: despite the use of inotropic agents (positive inotropic drugs) and/or temporary mechanical support (such as IABP or...
- 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...
- For patients who have undergone LVAD implantation, acute neurological injury occurring after implantation, including stroke, hypoxic encephalopathy...
- Acute myocardial infarction with mechanical complications, including ventricular septal defect, cardiac rupture, or papillary muscle rupture.
- Failed revascularization (for patients requiring right coronary revascularization), defined as a TIMI blood flow grade of 0 or 1 following...
- Active infection, meeting at least two of the following criteria: white blood cell count \> 12,500/μL, positive blood culture, or fever.
See the full eligibility criteria
Who can join
- 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...
- 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...
- ≥ 18 years old.
- The patient or the patient's legal representative agrees to sign the informed consent form.
What rules you out
- 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...
- 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.
- 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...
- Acute myocardial infarction with mechanical complications, including ventricular septal defect, cardiac rupture, or papillary muscle rupture.
- 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.
- Active infection, meeting at least two of the following criteria: white blood cell count \> 12,500/μL, positive blood culture, or fever.
- Thrombus in the right atrium, right ventricle, and/or pulmonary artery.
- History of mechanical valve replacement of the tricuspid or pulmonary valve.
- Severe tricuspid stenosis or regurgitation.
- Severe pulmonary valve stenosis or regurgitation.
- Severe pulmonary hypertension, defined as a pulmonary artery systolic pressure \> 60 mmHg.
- Current diagnosis of pulmonary embolism.
- History of pulmonary artery graft replacement (artificial vessel).
- Current use of a right heart assist device or extracorporeal membrane oxygenation (ECMO) device.
- Thrombosis of the internal jugular vein and deep veins of the lower extremities, and/or the presence of a vena cava filter.
- 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...
- Congenital heart disease that precludes device implantation, or an unrepairated atrial septal defect or patent foramen ovale.
- Allergy or intolerance to contrast agents, or intolerance to anticoagulant or antiplatelet therapy.
- History of thrombolytic therapy within the past 30 days, known coagulation disorders, or hematologic disorders causing blood cell fragility or hemolysis.
- Female patients who are pregnant or breastfeeding.
- Participation in any other clinical trial that may confound the study results or affect the study outcomes.
- Other circumstances deemed by the investigator to be incompatible with inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China. 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.