No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Supira Medical · Industry
Who this trial is looking for
This trial is looking for patients with heart failure who have low heart function and need extra support during a heart procedure. Participants will be assessed for their safety and eligibility to use the Supira System.
Are You a Good Fit for This Trial?
Rules you outSevere liver diseaseAortic valve diseaseAortic stenosis
You may be able to join if
I have heart failure and my heart function is low.
I have a disease affecting my left main coronary artery or my other coronary arteries.
I might need extra support during the heart procedure.
I can provide my consent or have someone to consent for me.
You may not be able to join if
I had a stroke in the past 6 months.
I have moderate or severe aortic valve disease.
I have liver disease that is not well controlled.
I am on dialysis or need ongoing kidney treatment.
I have had issues with low blood platelets related to heparin.
I am allergic to certain contrast agents or heparin.
I am breastfeeding or pregnant.
I am participating in another clinical study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
* Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disea…
Inclusion Criteria:
* Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
* Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease
* Subject may benefit from hemodynamic support beyond the index procedure
* Informed consent granted by the patient or legally authorized representative
Exclusion Criteria:
* Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
* Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
* Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient \>20 mmHg or valve area \<1.5 cm2 as assessed on TTE)
* Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
* Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
* Heparin-induced thrombocytopenia, current or any prior occurrences
* Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol
* Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g/L)
* Breastfeeding or pregnant
* Currently participating in active follow-up phase of another clinical study of an investigational drug or device
* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
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