Status:
TERMINATED
Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
Lead Sponsor:
Artivion Inc.
Conditions:
Congenital Heart Disease
Cardiac Anomaly
Eligibility:
All Genders
Brief Summary
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 patc...
Detailed Description
This study will include a review of approximately 300 charts spanning the implant period of January 1, 2018 through June 30, 2019. Those that meet the inclusion and exclusion criteria will undergo ful...
Eligibility Criteria
Inclusion
- Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium
Exclusion
- Subject required valve leaflet repair using PhotoFix
Key Trial Info
Start Date :
March 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05314868
Start Date
March 31 2022
End Date
November 30 2022
Last Update
January 13 2023
Active Locations (1)
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1
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115