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 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 during a high-risk PCI procedure.

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.

How is the KARDION Cory P4 System treatment different from other treatments for coronary artery disease?

The KARDION Cory P4 System is a mechanical circulatory support device, which is unique because it provides assistance to the heart in patients with coronary artery disease, especially those experiencing cardiogenic shock (a condition where the heart suddenly can't pump enough blood). Unlike traditional drug therapies, this system offers direct mechanical support to maintain blood flow and organ perfusion, potentially serving as a bridge to recovery or transplantation. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment KARDION Cory P4 System for coronary artery disease?

Research on similar mechanical circulatory support devices shows they can improve heart function by increasing blood flow and supporting the heart during high-risk procedures. For example, devices like the Aortix™ and LionHeart LVD-2000 have been shown to provide effective support for heart failure and other cardiac conditions, suggesting potential benefits for coronary artery disease as well. ^{6 7 8 9 10}

Who Is on the Research Team?

William Nicholson, MD

Principal Investigator

Emory University

Samin Sharma, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

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

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]

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]

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 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]

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]

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]

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]

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]

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 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. England pubmed.ncbi.nlm.nih.gov

Aortix™: a novel intra-aortic entrainment pump. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The LionHeart LVD-2000: a completely implanted left ventricular assist device for chronic circulatory support. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Circulatory Mechanotherapeutics: Moving with the Force. [2019]

4. United States 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. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Temporary mechanical support of left ventricular failure following open heart surgery. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Successful use of a pneumatic biventricular assist device as a bridge to transplantation in cardiogenic shock. [2011]

7. England pubmed.ncbi.nlm.nih.gov

Mechanical circulatory support: a clinical reality. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Temporary Mechanical Circulatory Support in Cardiogenic Shock Patients after Cardiac Procedures: Selection Algorithm and Weaning Strategies. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Acute and chronic mechanical circulatory support]. [2007]

10. England 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. [2018]