Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

CryoLife

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02164201

BFM1301.000-M

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria include:

• Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).