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

NCT07704424 | Recruiting

• 1 other identifier: COREMED_CorVad_RS_FIM
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Right Heart Failure

Keywords

Right heart failure; pVAD; CorVad

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Death

  30 days after device explant, 90 days after device explant

• Major Bleeding

  30 days after device explant

• Major hemolysis

  30 days after device explant

• Pulmonary embolism

  30 days after device explant

• Tricuspid and/or pulmonary valve dysfunction

  30 days after device explant

Study Arms (1)

CorVad Percutaneous Ventricular Assist System

EXPERIMENTAL

Device model: CorVad RS

Device: CorVad Percutaneous Ventricular Assist System

Interventions

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.

CorVad Percutaneous Ventricular Assist System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

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

Study Sites (2)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaoli Shi

CONTACT

+86 13418601356; shixiaoli@coretechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CorVad Percutaneous Ventricular Assist System

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)