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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 full review and data extraction to be captured in the electronic database. Given the retrospective nature of the study design, a Waiver of Consent will be requested from the Institutional Review Board (IRB). Potential subjects this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. Targeted cardiac procedures include intracardiac repair (including annulus and septal repair), great vessel repair (including superior vena cava, inferior vena cava, pulmonary arteries, pulmonary veins, and ascending aorta), and suture line buttressing and pericardial closure. Follow-up data will be abstracted from the subject's medical record. Study specific testing, including imaging and laboratory testing, will not be required.

Official Title
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Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery

Conditions
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Congenital Heart Disease, Cardiac Anomaly

Intervention / Treatment
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* Device: PhotoFix


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary cohort<br>Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch. | Device: PhotoFix<br>* Surgical repair with patch.<br>* Other names: PhotoFix Decellularized Bovine Pericardium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Mortality | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause reoperation | 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. | Up to 5 years | 
| Device-related reoperation | The total number of unplanned reoperations required in patients over the follow-up period, which are determined by the surgeon to be device-related. | Up to 5 years | 
| Explant | The total number of device explants over the course of follow-up. | Up to 5 years | 
| Morbidity | The total number of any adverse event, with specific focus on cardiovascular complications which have the potential to be device-related. | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bovine pericardium patch, cardiac repair, cardiac reconstruction