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

Congenital Heart Disease Clinical Trial

— Retro-C  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05314868
• Other study ID #: PHF1901.000-M (11/19)
• Status: Terminated
• Start date: March 31, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Artivion Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Anomaly
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• PhotoFix
Surgical repair with patch.

Locations

Country	Name	City	State
United States	Children's Hospital of Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Artivion Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Mortality	Up to 5 years
Secondary	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
Secondary	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
Secondary	Explant	The total number of device explants over the course of follow-up.	Up to 5 years
Secondary	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