Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure

Overview

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

• Device CorVad Percutaneous Ventricular Assist System
  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.

Primary outcome measures

• The survival rate [Time frame: 30 days after device explant, or hospital discharge (whichever is longer), or to the induction of anesthesia to a longer-term therapy]

Secondary outcome measures (10)

• Death [Time frame: 30 days after device explant, 90 days after device explant]
• Major Bleeding [Time frame: 30 days after device explant]
• Major hemolysis [Time frame: 30 days after device explant]
• Pulmonary embolism [Time frame: 30 days after device explant]
• Tricuspid and/or pulmonary valve dysfunction [Time frame: 30 days after device explant]
• MACCE [Time frame: 30 days after device explant, 90 days after device explant]
• Changes in CVP [Time frame: 24 hours after CorVad support]
• Changes in CI [Time frame: 24 hours after CorVad support]
• Changes in LVAD flow [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]

Eligibility criteria

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:

• 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%.
• ≥ 18 years old.
• The patient or the patient's legal representative agrees to sign the informed consent form.

Exclusion criteria

• 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.
• 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 consciousness).
• 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 aortic dissection), etc.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

China · 2 centers

• The First Affiliated Hospital of Anhui Medical University — Hefei
• Beijing Anzhen Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07704424 · COREMED_CorVad_RS_FIM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗