Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

Study Overview
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Brief Summary
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Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)

Official Title
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Vortex - First in Human Study to Evaluate the Feasibility, Safety, Clinical and Technical Success of the Vortex Temporary Percutaneous, Transvalvular Circulatory Support System (Vortex System)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject will be considered for enrolment in the study if all of the following inclusion criteria are met, provided no exclusion criteria are met: IC1. Subject provides signed informed consent. IC2. Subject is ≥ 18 years and < 90 years of age. IC3 Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main -OR- Last remaining vessel -OR- Three vessel disease (≥ 50% diameter stenoses by visual estimate or total occlusion) Exclusion Criteria: A subject will be excluded from the study if any of the following exclusion criteria are met: EC1. Subject has had ST-elevation myocardial infarction (STEMI) within 24 hours. EC2. Subject has had pre-procedure cardiac arrest requiring cardiopulmonary resuscitation (CPR) within 24 hours of enrollment. EC3. Subject is in shock, defined as follows: Cardiac index (CI) < 2.2 L/min/m2 and pulmonary capillary wedge pressure (PCWP) > 15 mmHg -AND- Hypotension (systolic blood pressure < 90 mmHg for > 30 minutes) -OR- Need for supportive measures (i.e., inotropes or mechanical support) to maintain systolic blood pressure ≥ 90 mmHg and end organ hypoperfusion (cool extremities or urine < 30 mL/hour and a heart rate > 60 beats per minute) EC4. Subject has left ventricular mural thrombus. EC5. Subject has a prosthetic aortic valve. EC6. Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy). EC7. Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as ≥ 2+). EC8. Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery. EC9. Subject has peripheral vessel disease (PVD) preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the 16 Fr introducer sheath. Note: Minimum required vessel diameter is > 5.5 mm. EC10. Subject has advanced renal dysfunction (AKIN Stage 3). EC11. Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin > 3× upper limit of normal (ULN) or international normalization ratio (INR) ≥ 2. EC12. Subject has had a recent (within 1 month) stroke or TIA. EC13. Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol. EC14. Subject has current or a history of heparin induced thrombocytopenia (HIT). EC15. Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.0. EC16. Subject has significant right heart failure (right atrial pressure [RAP] > 15 mmHg, right ventricular stroke work index [RVSWI] < 0.30 mmHg·L/m², pulmonary vascular resistance [PVR] > 3.6 Woods units). EC17. Subject requires mechanical ventilation. EC18. Subject has an atrial or ventricular septal defect (including post-infarct ventricular septal defect [VSD]). EC19. Subject has left ventricular rupture. EC20. Subject has cardiac tamponade. EC21. Subject has severe pulmonary disease (FEV1 < 1L). EC22. Subject has sustained or non-sustained ventricular tachycardia. EC23. Subject is breast feeding or is pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open-label, single-arm feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortex Feasibility Study (Vortex FIH)<br>Vortex - First in Human Study to Evaluate the Feasibility, Safety, Clinical and Technical Success of the Vortex Temporary Percutaneous, Transvalvular Circulatory Support System (Vortex System) | Device: Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)<br>* The Vortex System is indicated to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successful delivery of the device to the correct anatomical position and successful operation and removal of the Vortex circulatory support system | The Vortex system is indicated to provide temporary (≤ 4 hours) circulatory intended to be used to support in patients undergoing high-risk percutaneous coronary intervention (HR PCI). | 
| Clinical success | No conversion to open heart surgery; and no in-hospital mortality | The Vortex system is indicated to provide temporary (≤ 4 hours) circulatory intended to be used to support in patients undergoing high-risk percutaneous coronary intervention (HR PCI). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical circulatory support, High risk percutaneous coronary intervention (HR PCI)