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

Terminated

• Conditions: Congenital Heart Disease; Cardiac Anomaly
• Interventions: Device: PhotoFix

• Registration Number: NCT05314868
• Lead Sponsor: Artivion Inc.

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 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

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.

Study Timeline

• Study First Submitted: 2022-03-28
• Study Start: 2022-03-31
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-06
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary cohort	PhotoFix	Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch.

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 5 years	Mortality

Secondary Outcome Measures

Name	Time	Method
All-cause reoperation	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.
Morbidity	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.
Explant	Up to 5 years	The total number of device explants over the course of follow-up.
Device-related reoperation	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.

Trial Locations

Locations (1)

Children's Hospital of Boston; 🇺🇸 Boston, Massachusetts, United States