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

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ClinicalTrials.gov Identifier: NCT05314868
Recruitment Status : Terminated (Sponsor declined to continue funding the study.)
First Posted : April 6, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Artivion Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Congenital Heart Disease Cardiac Anomaly 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 Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery
Actual Study Start Date : March 31, 2022
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: PhotoFix Decellularized Bovine Pericardium


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 5 years ]
    Mortality


Secondary Outcome Measures :
  1. All-cause reoperation [ Time Frame: 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.

  2. Device-related reoperation [ Time Frame: 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.

  3. Explant [ Time Frame: Up to 5 years ]
    The total number of device explants over the course of follow-up.

  4. Morbidity [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05314868


Locations
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United States, Massachusetts
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Artivion Inc.
Investigators
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Principal Investigator: Christopher Baird, MD Boston Children's Hospital
More Information
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Responsible Party: Artivion Inc.
ClinicalTrials.gov Identifier: NCT05314868    
Other Study ID Numbers: PHF1901.000-M (11/19)
First Posted: April 6, 2022    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023

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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
Keywords provided by Artivion Inc.:
bovine pericardium patch
cardiac repair
cardiac reconstruction
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities