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 below

Select...

I am between 18 and 90 years old.

Select...

My heart's pumping ability is below normal, and I have high-risk heart artery disease.

Select...

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.

Select...

I do not have serious heart or lung conditions.

Select...

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.

Select...

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

Select...

I had a cardiac arrest and needed CPR or defibrillation within the last week.