Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor declined to continue funding the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary cohort | Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PhotoFix | Device | Surgical repair with patch. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Mortality | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Device-related reoperation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Baird, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Boston | Boston | Massachusetts | 02115 | United States |
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Explant | The total number of device explants over the course of follow-up. | Up to 5 years |
| 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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |