Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

Study Overview
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Brief Summary
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This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.

Official Title
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Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery

Conditions
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Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is undergoing an elective cardiac or cardiovascular procedure; Subject is willing and able to give prior written informed consent for investigation participation; and Subject is > 18 years of age. Intraoperative inclusion criteria include: • Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples). Exclusion Criteria: • Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde; Subject with active infection (either systemic or in the repair region); Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator; Subject diagnosed with a coagulation disorder; Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism); Subject whose life expectancy is less than that required for the prescribed follow-up duration; Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or Subject who is immunocompromised. Intraoperative exclusion criteria include: • Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of haemostasis |  | 3 minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to haemostasis |  | measured through to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)