Mechanical Circulatory Support for Coronary Artery Disease
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kardion Inc
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Recent revascularization, STEMI, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
678910Eligibility Criteria
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.
+3 more
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.
+5 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: KARDION Cory P4 SystemExperimental Treatment1 Intervention
Group II: Commercial ControlActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount SinaiNew York, NY
Dignity Health - Chandler Regional Medical CenterChandler, AZ
HonorHealth Research and Innovation InstituteScottsdale, AZ
Arkansas Cardiology, P.A.Little Rock, AR
More Trial Locations
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Who Is Running the Clinical Trial?
Kardion IncLead Sponsor
References
Aortix™: a novel intra-aortic entrainment pump. [2021]Use of short-term mechanical circulatory support pumps for cardiogenic shock, decompensated heart failure and high-risk coronary intervention is growing. The Aortix™ device (Procyrion, TX, USA) is the first axial-flow pump positioned in the aorta and is designed to provide short-term hemodynamic support. This review discusses the field of continuous flow aortic pumps and focuses specifically on emerging preclinical and clinical data supporting the development of these technologies.
The LionHeart LVD-2000: a completely implanted left ventricular assist device for chronic circulatory support. [2019]Management of patients with end-stage cardiac disease remains a vexing problem. Limitations in medical management and a fixed supply of donor organs for cardiac transplant have a continued impact on this growing population of patients. Mechanical circulatory support has proved very successful as a means of bridging patients to cardiac transplant when all medical options have been exhausted. The development of a chronic system of circulatory support has been underway at the Pennsylvania State University for nearly 30 years. These efforts have been recently merged with the industrial partnership with Arrow International toward the development of the LionHeart LVD-2000 (Arrow International, Reading, PA) completely implanted left ventricular support system. We present an overview of the system, details of implantation, a review of preclinical studies, and a synopsis of the first European implants. Early results have demonstrated the system to be safe, effective, and reliable. Transcutaneous energy transmission and the compliance chamber have been validated.
Circulatory Mechanotherapeutics: Moving with the Force. [2019]This review describes the current state of advancements in mechanical circulatory support (MCS) devices with significantly improved hemodynamic performance and decreased adverse events. Novel considerations for future MCS designs that impart spiral flow regimes will be detailed.
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]Mechanical circulatory support devices (MCSDs) have gained widespread clinical acceptance as an effective heart failure (HF) therapy. The concept of harnessing the kinetic energy (KE) available in the forward aortic flow (AOF) is proposed as a novel control strategy to further increase the cardiac output (CO) provided by MCSDs. A complete mathematical development of the proposed theory and its application to an example MCSDs (two-segment extra-aortic cuff) are presented. To achieve improved device performance and physiologic benefit, the example MCSD timing is regulated to maximize the forward AOF KE and minimize retrograde flow. The proof-of-concept was tested to provide support with and without KE control in a computational HF model over a wide range of HF test conditions. The simulation predicted increased stroke volume (SV) by 20% (9 mL), CO by 23% (0.50 L/min), left ventricle ejection fraction (LVEF) by 23%, and diastolic coronary artery flow (CAF) by 55% (3 mL) in severe HF at a heart rate (HR) of 60 beats per minute (BPM) during counterpulsation (CP) support with KE control. The proposed KE control concept may improve performance of other MCSDs to further enhance their potential clinical benefits, which warrants further investigation. The next step is to investigate various assist technologies and determine where this concept is best applied. Then bench-test the combination of kinetic energy optimization and its associated technology choice and finally test the combination in animals.
Temporary mechanical support of left ventricular failure following open heart surgery. [2017]Patients coming to open heart surgery with advanced cardiac dysfunction may require mechanical cardiac support to avoid life-threatening low cardiac output in the postoperative period. 15 patients who could not be withdrawn from cardiopulmonary bypass because of low cardiac output were supported with a left heart bypass system (left atrium to ascending aorta). Ten were ultimately separated from the device, 6 were dismissed from the hospital and 4 remain well (the longest 2.6 years postoperative). A major asset of the device is that thoracic reentry is not required when support is discontinued.
Successful use of a pneumatic biventricular assist device as a bridge to transplantation in cardiogenic shock. [2011]Mechanical circulatory support is a highly effective technology to maintain organ perfusion in patients with cardiogenic shock as a bridge to transplantation. Although implantation of a left ventricular assist device alone is often the preferred configuration, patients with biventricular failure and significant end-organ dysfunction often require biventricular assistance.
Mechanical circulatory support: a clinical reality. [2017]Mechanical circulatory support is becoming an alternative therapeutic option for patients in cardiogenic shock or advanced cardiac failure who cannot be improved by maximal medical therapy. More than 30 years of engineering development and clinical research have led to a level of efficacy and reliability of ventricular assist devices, which allows promotion of this approach for the most difficult patients. Uses include a gaining-time strategy as a bridge to cardiac transplantation or recovery of native cardiac function, as well as permanent support with the device. The large variety of devices permits every cardiac surgical unit, even those not used to cardiac transplantation, to propose this option to the patient. Recent experience with small silent implantable pumps suggests that the pioneering period of mechanical circulatory support is probably over, and the time has come for precise prospective trials to optimize both patient selection and the timing for utilization. In countries where cardiac transplantation has not developed, there is now an easily accessible technique for management of patients with cardiac failure.
Temporary Mechanical Circulatory Support in Cardiogenic Shock Patients after Cardiac Procedures: Selection Algorithm and Weaning Strategies. [2023]Mechanical circulatory support has proven effective in managing postcardiotomy cardiogenic shock by stabilizing patients' hemodynamics and ensuring adequate organ perfusion. Among the available device modalities, the combination of extracorporeal life support and a microaxial flow pump for left ventricular unloading has emerged as a valuable tool in the surgical armamentarium. In this publication, we provide recommendations for the application and weaning of temporary mechanical circulatory support in cardiogenic shock patients, derived from a consensus among leading cardiac centers in German-speaking countries.
[Acute and chronic mechanical circulatory support]. [2007]Mechanical circulatory support and mechanical unloading of the left ventricle become more and more routine in clinical treatment regimens of both acute and chronic heart failure. Along with increasing availability of different cardiac assist systems one can adjust the degree of support according to the clinical situation. We report about our experience in the period between January 1994 and May 1995 with following assist systems: Hemopump, centrifugal pumps, Medos, HIAVAD and Novacor. We implanted those devices in 21 patients out of following indications: postinfarct--cardiac failure (CF), postcardiotomy CF, elective postcardiotomy support, myocarditis CF and "bridge" to transplant. Ten patients survived the period of mechanical support and could be weaned successfully. Circulatory support was sufficient in all cases, indication, time of implantation, anticoagulation and prevention of infections are discussed.
Combined pulmonary and left ventricular support with veno-pulmonary ECMO and impella 5.0 for cardiogenic shock after coronary surgery. [2018]Mechanical circulatory support is a common practice nowadays in the management of patients after cardiogenic shock due to myocardial infarction. The single or combined use of one or more devices for mechanical support depends not only on the advantage or disadvantage of these devices but also on the timing of use of these devices before the development of multi organ failure. In our case we used more than one tool for mechanical circulatory support during the prolonged and complicated course of our patient with postcardiotomy cardiogenic shock after coronary artery bypass surgery.