VIOLA Post Market Surveillance Clinical Protocol

The goal of this post marketing surveillance clinical trial is to collect post market data on the safety and performance of VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Data will be collected intraoperatively, at discharge, at 6 weeks, and at 9 months post CABG.

Inclusion criteria

• Patient scheduled for isolated CABG on clinical grounds
• One or more bypass grafts originating from the aorta
• Ability to give their informed written consent
• Ability and willingness to comply with study follow up requirements
• Patient is ≥ 18 years of age

Exclusion criteria

• Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
• Prior clinical stroke less than one year before surgery
• Pre-operative neurological deficits
• Chronic atrial fibrillation
• Aortic external diameter less than 25 mm measured intraoperatively
• No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta).
• Symptomatic carotid disease
• Acute MI within 24 hours of planned surgery
• EuroScore II ≥ 4
• Known allergy to nickel
• Women of child bearing age
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.