Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery

Stopped early

Conditions studied: Congenital Heart Disease, Cardiac Anomaly

In brief

The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical repair or reconstruction procedure. PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques.

Key facts

Study ID

NCT05314868

Run by

Artivion Inc.

People needed

10

Starts

2022-03-31

Expected to finish

2022-11-30

Last updated by the study team

2023-01-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium

You may not qualify if…

• Subject required valve leaflet repair using PhotoFix

Where it is running

• Children's Hospital of Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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