Single Center,
Prospective, Randomized, Blinded Evaluator Trial to Determine the Effect
of Cormatrix Pericardial Patch on In Vivo Remodeling and Reducing Adhesions
in Pediatric Cardiac Surgery Patients with a Planned or Anticipated
Re-operation
Sponsor:
CorMatrix Cardiovascular, Inc.
Investigator:
Eric Mendeloff, MD
Research Coordinator: Tina Worley, RN, BSN
Designated
Site: Medical City Dallas
The primary objective
of this trial is to determine the safety and effectiveness of the
CorMatrix Pericardial Patch in remodeling of the patch into pericardium
and reducing adhesions around the patch in pediatric cardiac surgery
patients likely to undergo a second thoracic surgery within one year.