percutaneous coronary intervention Percutaneous Transluminal Coronary Angioplasty Ventricular Ejection Fraction Cardiac Output
Conditions
Interventions
Temporary mechanical circulatory support during high risk percutaneous coronary intervention.
Experimental Device
Sponsors
Kardion, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: Subject age at least 18 and less than than or equal to 90 years of age The patient requires a non-emergent PCI and has an LV ejection fraction of < 50% requiring hemodynamic support during the procedure and has been deemed to be suboptimal for cardiac surgery AND at high risk due to any of the following: Unprotected Left Main Stenosis Last remaining vessel Significant three vessel disease (or two-vessel disease in a dominant left system) The patient is willing and able to comply with the protocol-specified treatment and follow-up evaluations The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion criteria
Exclusion criteria: Subjects must not meet any of the following criteria: Emergency Procedure Any prior coronary revascularization or revascularization attempt within 30 days prior to procedure STEMI within 7 days prior to procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of greater than or equal to 2 mm (0.2 mV) in men or greater than or equal to 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of greater than or equal to 1 mm (0.1 mV) in other contiguous chest leads or the limb leads Cardiac arrest within 7 days prior to procedure requiring CPR or defibrillation Subject indicated to require cardiac support with an MCS System post procedure Subjects with sustained ventricular tachycardia or repetitive / prolonged non-sustained ventricular tachycardia or complex ventricular ectopy Left ventricular thrombus Significant right heart failure Combined cardiorespiratory failure Presence of an atrial or ventricular septal defect (including post-infarct VSD) Hypertrophic obstructive cardiomyopathy (HOCM) Cardiogenic shock (Cardiac index < 1.8 l/min/meters squared) or pre-procedure use of inotropic or pressor therapy within 72 hours of the planned index procedure Moderate or severe aortic valve insufficiency, stenosis or aortic valve replacement (mechanical prosthesis) Aortic vascular disease (i.e. aortic aneurysm, dissection, extreme tortuosity or calcification creating additional risk to the placement of an MCS device) CVA/TIA within 90 days prior to procedure Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count less than or equal to 100,000 or spontaneous INR greater than or equal to 1.5 or known fibrinogen less than or equal to 1.5 g/l) Known hemoglobin diseases, such as sickle cell anemia or thalassemia Patient has been diagnosed with or is recently suffering from infectious disease Chronic renal dysfunction (eGFR < 30 mL/min/1.73 meters squared) and patients requiring renal replacement therapy with dialysis History of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) Known or suspected severe pulmonary disease (e.g. forced expiratory volume (FEV)1 < 1.0 l/s) or requiring supplemental oxygen Allergy, sensitivity or tolerance to anesthesia, heparin, aspirin, adenosine, diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT) Any non-cardiac condition with life expectancy < 3 years (e.g. cirrhosis, oxygen or oral steroid dependent COPD, cancer, etc.) Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for > 24 hours with full neurologic recovery) Decompensated heart failure within the last 3 months that required hospitalization (admitting diagnosis) Morbid obesity (BMI greater than or equal to 40 kg/meters squared) Patients with an organ transplant Patients with implanted left ventricular assist device Cardiac tamponade Left ventricular rupture Tuberculosis, hepatitis, HIV-infection or other severe viral diseases Suspected or known pregnancy or lactating women Active COVID-19 infection Anatomic situations that limit delivery of the MCS Device, like severe peripheral arterial occlusive disease (PAOD) Other diseases or therapies that restrict the use of an MCS Device Subject has other medical,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device related cardiac death Procedure through discharge or 3 days whichever comes first Death | — |
Secondary
| Measure | Time frame |
|---|---|
| MI Procedure through discharge or 3 days whichever comes first MI Defined as troponin above 99th percentile upper reference limit ,Surgical intervention due to device compromise Procedure through discharge or 3 days whichever comes first Surgery,Device-related access site complication requiring intervention Procedure through discharge or 3 days whichever comes first Observation,Device-related major bleeding complication (BARC greater than 3) Procedure through discharge or 3 days whichever comes first Observation,Device-related limb ischemia Procedure through discharge or 3 days whichever comes first Ovservation,Device-related cerebrovascular accident (CVA) Procedure through discharge or 3 days whichever comes first Observation | — |
Countries
Mexico
Contacts
Public ContactGuering Lidt
Instituto Nacional de Cardiologia Ignacio Chavez
Outcome results
None listed