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Right Heart FailureNCT07704424

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

A study testing CorVad Percutaneous Ventricular Assist System in people with Right Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Right Heart Failure
What is being tested?
CorVad Percutaneous Ventricular Assist System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesChina
Study dates
2 Jun 2026to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoli Shi contact

+86 13418601356

shixiaoli@coretechmed.com

China2 sites, 2 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

    Ming Gong, Professor, +86 18600569803, gongming@mail.ccmu.edu.cn

    Ming Gong, Professor

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Chengxin Zhang, Professor, +86 18613997815, zhangchengxin@ahmu.edu.cn

    Not yet recruiting

Other trials in China

About this study

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.

Being tested
CorVad Percutaneous Ventricular Assist System
Keywords
Right heart failure, pVAD, CorVad
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CorVad Percutaneous Ventricular Assist SystemDevice

    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.

Study groups in NCT07704424
Study groupRoleWhat they receive
CorVad Percutaneous Ventricular Assist SystemExperimentalDevice model: CorVad RS
Receives: Device: CorVad Percutaneous Ventricular Assist System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Death

    All-cause death

    Measured: 30 days after device explant, 90 days after device explant

  2. Major Bleeding

    MCS-ARC 3, 4, 5 type bleeding

    Measured: 30 days after device explant

  3. 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:

    1. Hemoglobinuria
    2. Anemia
    3. Hyperbilirubinemia
    4. Pumpmalfunctionand/orabnormalpumpparameters

    Measured: 30 days after device explant

  4. 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.

    Measured: 30 days after device explant

  5. 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.

    Measured: 30 days after device explant

  6. MACCE

    Major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke.

    Measured: 30 days after device explant, 90 days after device explant

  7. Changes in CVP

    Changes in central venous pressure (CVP) after CorVad support (compared to baseline), measured by central venous catheter or right heart catheter

    Measured: 24 hours after CorVad support

  8. Changes in CI

    Changes in cardiac index (CI) after CorVad support (compared to baseline), measured by right heart catheter or echocardiography

    Measured: 24 hours after CorVad support

  9. Changes in LVAD flow

    Changes in LVAD flow (if applicable) compared to baseline

    Measured: within 48 hours after CorVad support

  10. Decreased use of inotropes/vasopressor during support

    Measured: during CorVad support, after 30 days post explant and after 90 days post explant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start2 Jun 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
CorVad Percutaneous Ventricular Assist System
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704424
Sponsor's protocol ID
COREMED_CorVad_RS_FIM
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CorVad Percutaneous Ventricular Assist System in people with Right Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoli Shi (+86 13418601356, shixiaoli@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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