MedTrace Logo

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

NCT05314868 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease
  • Cardiac Anomaly

Interventions

DEVICE

PhotoFix

Surgical repair with patch.

Sponsors & Collaborators

  • Artivion Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Baird, MD · Boston Children's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05314868 on ClinicalTrials.gov