Mechanical Circulatory Support for Coronary Artery Disease

Recruiting at 16 trial locations

Overseen By Darin R. Lerew

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kardion Inc

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Recent revascularization, STEMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Index procedure

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the KARDION Cory P4 System, a mechanical support device for the heart, to determine its safety and effectiveness for individuals with serious coronary artery disease (blocked or narrowed heart arteries) requiring support during a challenging heart procedure called PCI. It aims to assist those with lower-than-normal heart function and complex heart artery issues. Individuals with complex coronary artery problems who need mechanical support during their PCI procedure might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could enhance future heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the KARDION Cory P4 System is safe for hemodynamic support during high-risk PCI procedures?

Research shows that the KARDION Cory P4 System is being tested to assist patients with coronary artery disease during high-risk procedures. Specific information from earlier studies about its safety in humans is not available. The trial is marked as "Not Applicable" for its phase, indicating it may still be in early testing stages or not following the usual clinical trial phases. As a result, detailed safety information might not yet be available.

Potential participants should ask the researchers about any known side effects or issues from other trials with the device. Ensure all necessary information is gathered to make an informed decision about joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The KARDION Cory P4 System is unique because it offers a mechanical circulatory support option for patients with coronary artery disease, providing an innovative approach compared to traditional treatments like medication, lifestyle changes, or invasive procedures such as angioplasty and coronary artery bypass grafting. Unlike these standard treatments, the KARDION Cory P4 System aims to mechanically assist the heart, potentially improving blood flow and reducing the heart's workload without the need for major surgery. Researchers are excited about this treatment because it could offer a less invasive solution with quicker recovery times and the possibility of improving quality of life for patients who may not be candidates for surgery.

What evidence suggests that the KARDION Cory P4 System is effective for coronary artery disease?

Research on the KARDION Cory P4 System, which participants in this trial may receive, shows promise for individuals needing extra heart support during high-risk procedures for coronary artery disease. Early studies suggest that this device can stabilize blood flow, a crucial factor during complex heart surgeries. Although direct data from human trials remains limited, the device operates similarly to other systems that have successfully provided temporary heart support. This system assists the heart by taking over some of its pumping work, potentially reducing complications during surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Samin Sharma, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

William Nicholson, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 90 with severe coronary artery disease, needing support during a high-risk procedure to open blocked arteries. Candidates should have complex blockages in one or more arteries or require advanced techniques like calcium modification. It's not suitable for those who aren't fit for Percutaneous Mechanical Circulatory Support as per their heart team.

Inclusion Criteria

Confirmed access site vasculature greater than 5.5 mm

I am willing and able to follow the study's treatment and check-up schedule.

My heart team has approved me for a procedure to open my heart's arteries with support from a device.

Exclusion Criteria

I do not have serious heart or lung conditions.

Current participation in another investigational drug or device trial

I had a type of heart attack without major artery blockage within the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the high-risk PCI procedure with the KARDION CORY P4 System for hemodynamic support

Index procedure

Follow-up

Participants are monitored for safety and effectiveness outcomes, including MACCE and device-related safety events

30 days

What Are the Treatments Tested in This Trial?

Interventions

• KARDION Cory P4 System

Trial Overview The KARDION CORY P4 System, a device providing hemodynamic support, is being tested during high-risk PCI procedures (a type of heart surgery). The goal is to assess its safety and effectiveness within the first 30 days after use.

How Is the Trial Designed?

Group I: KARDION Cory P4 System Experimental Treatment 1 Intervention

Group II: Commercial Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Kardion Inc

Lead Sponsor

Trials

1

Recruited

310+

Published Research Related to This Trial

In a study involving 15 patients with advanced cardiac dysfunction undergoing open heart surgery, a left heart bypass system was used to provide mechanical support when low cardiac output prevented withdrawal from cardiopulmonary bypass.

Out of the 15 patients, 10 were successfully separated from the device, with 6 discharged from the hospital and 4 remaining well up to 2.6 years post-surgery, highlighting the device's effectiveness and the advantage of not requiring thoracic reentry for discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary mechanical support of left ventricular failure following open heart surgery. Litwak, RS., Lukban, SB., Jurado, RA., et al.[2017]

Mechanical circulatory support, particularly through ventricular assist devices, is a viable treatment option for patients with cardiogenic shock or advanced cardiac failure who do not respond to standard medical therapies, based on over 30 years of research and development.

The introduction of small, silent implantable pumps marks a significant advancement in this field, suggesting that it's time for targeted clinical trials to refine patient selection and timing for the use of these devices, especially in regions lacking access to cardiac transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical circulatory support: a clinical reality. Loisance, D.[2017]

In a study involving 21 patients with various types of heart failure, mechanical circulatory support devices were successfully implanted, demonstrating effective support for patients in critical conditions.

Out of the 21 patients, 10 were able to survive and be weaned off the mechanical support, indicating a significant potential for recovery and successful management of heart failure with these assist systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acute and chronic mechanical circulatory support]. Waldenberger, FR., Laube, HR., Konertz, W.[2007]

The LionHeart LVD-2000 is a completely implanted left ventricular support system developed through a collaboration between Pennsylvania State University and Arrow International, aimed at providing mechanical circulatory support for patients with end-stage cardiac disease.

Early results from the first European implants indicate that the system is safe, effective, and reliable, with successful validation of its transcutaneous energy transmission and compliance chamber features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The LionHeart LVD-2000: a completely implanted left ventricular assist device for chronic circulatory support. Mehta, SM., Pae, WE., Rosenberg, G., et al.[2019]

The Aortix™ device is the first axial-flow pump designed to be positioned in the aorta, providing short-term hemodynamic support for patients experiencing cardiogenic shock and decompensated heart failure.

The use of mechanical circulatory support pumps like Aortix™ is increasing, indicating a growing recognition of their potential benefits in high-risk coronary interventions and critical heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aortix™: a novel intra-aortic entrainment pump. Kapur, NK., Esposito, ML., Whitehead, E.[2021]

In a study of 80 patients with severe biventricular failure, the use of pneumatic biventricular assist devices resulted in a 71.3% success rate for bridging to heart transplantation, with improved outcomes in more recent years (82% success from 2006-2008 compared to 63% from 2000-2005).

Post-transplant survival rates were high, with 89% of patients surviving one year after transplantation, which is comparable to the 92% survival rate of patients who did not require a ventricular assist device, indicating the effectiveness of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful use of a pneumatic biventricular assist device as a bridge to transplantation in cardiogenic shock. Moriguchi, J., Davis, S., Jocson, R., et al.[2011]

Recent advancements in mechanical circulatory support (MCS) devices have led to improved hemodynamic performance and fewer adverse events, particularly through innovations like magnetically levitated impellers and hydrodynamic bearings.

Studies suggest that incorporating spiral flow designs in MCS can enhance endothelial function by reducing jet impact and improving wall shear stress, addressing some of the vascular complications associated with traditional MCS devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulatory Mechanotherapeutics: Moving with the Force. Zhang, PH., Kresh, JY.[2019]

Mechanical circulatory support is effective in treating postcardiotomy cardiogenic shock by stabilizing hemodynamics and ensuring proper organ perfusion.

The combination of extracorporeal life support and a microaxial flow pump for left ventricular unloading is recommended as a valuable approach for managing these patients, based on expert consensus from leading cardiac centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Mechanical Circulatory Support in Cardiogenic Shock Patients after Cardiac Procedures: Selection Algorithm and Weaning Strategies. Nersesian, G., Ott, S., Fardman, A., et al.[2023]

Mechanical circulatory support devices (MCSDs) can be enhanced by utilizing the kinetic energy from forward aortic flow, potentially improving heart failure treatment outcomes.

In simulations, applying kinetic energy control to an MCSD resulted in a 20% increase in stroke volume and a 23% increase in cardiac output, indicating significant improvements in heart function during severe heart failure conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Idea to Improve Cardiac Output of Mechanical Circulatory Support Devices by Optimizing Kinetic Energy Transfer Available in Forward Moving Aortic Blood Flow. Qureshi, MB., Glower, J., Ewert, DL., et al.[2018]

The combined use of Impella 5.0 and veno-pulmonary extracorporeal membrane oxygenation (VP-ECMO) effectively managed biventricular failure in a 52-year-old patient after coronary artery bypass surgery, demonstrating the potential of these devices as a bridge to further mechanical support or heart transplantation.

The patient remained stable on both devices for 14 days before receiving a Heart Mate II left ventricular assist device, ultimately leading to a successful heart transplant six months later, indicating the efficacy and safety of this combined approach in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined pulmonary and left ventricular support with veno-pulmonary ECMO and impella 5.0 for cardiogenic shock after coronary surgery. Sayed, S., Schimmer, C., Shade, I., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06445608

PIvotal Trial of the KARDION Cory P4 MechANical ... This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support.

2. withpower.com withpower.com/trial/phase-coronary-artery-disease-6-2024-bb299

Mechanical Circulatory Support for Coronary Artery Disease This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support ...

3. mountsinai.org mountsinai.org/clinical-trials/search?keywords=Coronary%20Artery%20Disease

Coronary Artery Disease This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06445608/pivotal-trial-of-the-kardion-cory-p4-mechanical-circulatory-support-system

PIvotal Trial of the KARDION Cory P4 MechANical ... This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support.

5. thechristhospital.com thechristhospital.com/services/research/lindner/heart

Heart and Vascular Clinical Trials ​Kardion Picante, ​The purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require ...