VIOLA Post Market Surveillance Clinical Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2024-07-16

Brief Summary

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The goal of this post marketing surveillance clinical trial is to learn about 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. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CABG surgery with use of VIOLA

patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses

Group Type EXPERIMENTAL

VIOLA proximal seal

Intervention Type DEVICE

VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses

Interventions

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VIOLA proximal seal

VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No