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Mechanical Circulatory Support
Mechanical Circulatory Support for Coronary Artery Disease
N/A
Recruiting
Research Sponsored by Kardion Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject age ≥ 18 and ≤ 90 years at the time of screening
Subject has an LV ejection fraction of < 50% (within 90 days of index procedure) AND is at high-risk due to specific coronary artery disease criteria
Must not have
STEMI within 7 days prior to index procedure
Various cardiac conditions including left ventricular thrombus, right heart failure, severe pulmonary hypertension, cardiorespiratory failure, and more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index procedure through 30-day follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to show how safe and effective the KARDION CORY P4 System is for patients who need help with their heart during a risky heart procedure.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, mechanical circulatory support devices can generally cause bleeding complications, blood clots, infection risk at the insertion site, and may affect organ function due to changes in blood flow.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 90 years old.
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My heart's pumping ability is below normal, and I have high-risk heart artery disease.
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My heart team has approved me for a procedure to open my heart's arteries with support from a device.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a major heart attack within the last 7 days.
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I do not have serious heart or lung conditions.
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I do not have a history of stroke, severe infections, kidney or liver issues, severe lung disease, specific drug allergies, or any condition that would limit my life expectancy to under 3 years.
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I had a type of heart attack without major artery blockage within the last week.
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I had a cardiac arrest and needed CPR or defibrillation within the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device-Related Safety
MACCE
Secondary study objectives
Death
Individual MACCE components
Procedural Success
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: KARDION Cory P4 SystemExperimental Treatment1 Intervention
Group II: Commercial ControlActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Kardion IncLead Sponsor
Samin Sharma, MDStudy ChairIcahn School of Medicine at Mount Sinai
William Nicholson, MDStudy ChairEmory University