NCT05314868

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

March 28, 2022

Last Update Submit

January 12, 2023

Conditions

Congenital Heart DiseaseCardiac Anomaly

Keywords

bovine pericardium patchcardiac repaircardiac reconstruction

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Mortality

    Up to 5 years

Secondary Outcomes (4)

  • All-cause reoperation

    Up to 5 years

  • Device-related reoperation

    Up to 5 years

  • Explant

    Up to 5 years

  • Morbidity

    Up to 5 years

Study Arms (1)

Primary cohort

Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch.

Device: PhotoFix

Interventions

PhotoFixDEVICE

Surgical repair with patch.

Also known as: PhotoFix Decellularized Bovine Pericardium
Primary cohort

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium

You may not qualify if:

  • Subject required valve leaflet repair using PhotoFix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christopher Baird, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 6, 2022

Study Start

March 31, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

US(1)