Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
Sponsored by Artivion Inc.
About this trial
Last updated 2 years ago
Study ID
PHF1901.000-M (11/19)
Status
Terminated
Type
Observational
Placebo
No
Accepting
All
All
Trial Timing
Ended 3 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium
Exclusion Criteria
- Subject required valve leaflet repair using PhotoFix