Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery (Retro-C)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05314868|
Recruitment Status : Terminated (Sponsor declined to continue funding the study.)
First Posted : April 6, 2022
Last Update Posted : January 13, 2023
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease Cardiac Anomaly||Device: PhotoFix|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery|
|Actual Study Start Date :||March 31, 2022|
|Actual Primary Completion Date :||November 30, 2022|
|Actual Study Completion Date :||November 30, 2022|
Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch.
Surgical repair with patch.
Other Name: PhotoFix Decellularized Bovine Pericardium
- Overall survival [ Time Frame: Up to 5 years ]Mortality
- All-cause reoperation [ Time Frame: Up to 5 years ]The total number of unplanned reoperations required in patients over the follow-up period, which include the repair or alteration of the surgical area around the patch. Patients with planned reoperations, such as CHD staged surgeries, will not be considered.
- Device-related reoperation [ Time Frame: Up to 5 years ]The total number of unplanned reoperations required in patients over the follow-up period, which are determined by the surgeon to be device-related.
- Explant [ Time Frame: Up to 5 years ]The total number of device explants over the course of follow-up.
- Morbidity [ Time Frame: Up to 5 years ]The total number of any adverse event, with specific focus on cardiovascular complications which have the potential to be device-related.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05314868
|United States, Massachusetts|
|Children's Hospital of Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Christopher Baird, MD||Boston Children's Hospital|