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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Aortic Aneurysm; Aortic Valve Replacement; Type A Aortic Dissection; Cardiovascular Procedures

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • German Heart Center
• Italy
  • Milan, Italy
    • San Raffale Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac or cardiovascular procedures, including, but not limited to:

Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection (where BioFoam is limited to the anastomotic site)

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Achievement of haemostasis	3 minutes after application

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to haemostasis	measured through to 10 minutes

Collaborators and Investigators

• Sponsor: CryoLife Europa
• Investigators: Principal Investigator: Bernhard Voss, PD Dr Med, Deutsches Herzzentrum Muenchen; Principal Investigator: Ottavio Alfieri, Professor, San Raffale Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: BFM1301.000-M