Avicena LVDP Validation Study

Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.

Inclusion criteria

• Adult subjects >21 years of age.
• Referred for non-emergent left heart catheterization inclusive of direct measurement of LVDP as part of routine clinical management, to be performed from a femoral or radial access site.
• Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records.
• Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.

Exclusion criteria

• Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support.
• Carotid pulse is not palpable by a trained study researcher.
• History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck).
• History of significant or symptomatic carotid artery disease, including TIA, ultrasound evidence of >60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery.
• Open skin lesions at the site of Vivio application / examination.
• Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.).
• Inability to obtain brachial artery blood pressure.