Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery (Retro-C)

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

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease; Cardiac Anomaly
• Intervention / Treatment: Device: PhotoFix

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital of Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary cohort; Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch.	Device: PhotoFix; Surgical repair with patch.; Other Names: PhotoFix Decellularized Bovine Pericardium

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Artivion Inc.
• Investigators: Principal Investigator: Christopher Baird, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cardiac repair; bovine pericardium patch; cardiac reconstruction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: PHF1901.000-M (11/19)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes