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

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

Tracking Information

• First Submitted Date: March 28, 2022
• First Posted Date: April 6, 2022
• Last Update Posted Date: January 13, 2023
• Actual Study Start Date: March 31, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2022)

Overall survival [ Time Frame: Up to 5 years ]

Mortality

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 4, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
• Official Title: Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery
• 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.
• 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
• Study Design: Observational Model: Other; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Congenital Heart Disease
• Cardiac Anomaly

Intervention

Device: PhotoFix

Surgical repair with patch.

Other Name: PhotoFix Decellularized Bovine Pericardium

Study Groups/Cohorts

Primary cohort

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

Intervention: Device: PhotoFix

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 12, 2023): 10
• Original Estimated Enrollment (submitted: April 4, 2022): 100
• Actual Study Completion Date: November 30, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05314868
• Other Study ID Numbers: PHF1901.000-M (11/19)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Artivion Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Artivion Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christopher Baird, MD; Boston Children's Hospital

• PRS Account: Artivion Inc.
• Verification Date: January 2023