Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02164201

Enrollment

Registered

2014-06-16

Start date

2014-08-31

Completion date

2015-07-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Achievement of haemostasis	3 minutes after application

Secondary

Measure	Time frame
Time to haemostasis	measured through to 10 minutes

Countries

Germany, Italy

Outcome results