Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

Completed

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

• Registration Number: NCT02164201
• Lead Sponsor: CryoLife Europa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-16
• Study Start: 2014-08
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of haemostasis	3 minutes after application

Secondary Outcome Measures

Name	Time	Method
Time to haemostasis	measured through to 10 minutes

Trial Locations

Locations (2)

San Raffale Hospital; 🇮🇹 Milan, Italy

German Heart Center; 🇩🇪 Munich, Germany