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

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 Overview

• Status: Recruiting
• Conditions: Right Heart Failure
• Intervention / Treatment: Device: CorVad Percutaneous Ventricular Assist System

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoli Shi; Phone Number: +86 13418601356; Email: shixiaoli@coretechmed.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Not yet recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Chengxin Zhang, Professor; Phone Number: +86 18613997815; Email: zhangchengxin@ahmu.edu.cn
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Ming Gong, Professor; Phone Number: +86 18600569803; Email: gongming@mail.ccmu.edu.cn
      • Principal Investigator: Ming Gong, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CorVad Percutaneous Ventricular Assist System; Device model: CorVad RS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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: Hemoglobinuria; Anemia; Hyperbilirubinemia; Pumpmalfunctionand/orabnormalpumpparameters	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

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pVAD; Right heart failure; CorVad
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: COREMED_CorVad_RS_FIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No