Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

Sponsor

CryoLife Europa (Industry)

Overall Status

Completed

CT.gov ID

NCT02164201

Collaborator

(none)

Enrollment

Locations

Duration (Months)

37.5

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Procedures Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Outcome Measures

Primary Outcome Measures

Achievement of haemostasis [3 minutes after application]

Secondary Outcome Measures

Time to haemostasis [measured through to 10 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Heart Center	Munich		Germany
2	San Raffale Hospital	Milan		Italy

Sponsors and Collaborators

CryoLife Europa

Investigators

Principal Investigator: Bernhard Voss, PD Dr Med, Deutsches Herzzentrum Muenchen
Principal Investigator: Ottavio Alfieri, Professor, San Raffale Hospital