Congenital Heart DiseaseRetro-CNCT05314868
Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery
An observational study of Congenital Heart Disease and Cardiac Anomaly, run by Artivion Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Cardiac Anomaly
- What is being tested?
- PhotoFix
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch.
Who may be able to join
- Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium
Who cannot join
- Subject required valve leaflet repair using PhotoFix
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Boston
Boston, Massachusetts, 02115
About this study
Official title: Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Cardiac Anomaly
- Being tested
- PhotoFix
- Keywords
- bovine pericardium patch, cardiac repair, cardiac reconstruction
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotoFixDevice
Also called PhotoFix Decellularized Bovine Pericardium
Surgical repair with patch.
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch. Receives: Device: PhotoFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Mortality
Measured: Up to 5 years
Secondary outcomes (4)
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.
Measured: Up to 5 years
Device-related reoperation
The total number of unplanned reoperations required in patients over the follow-up period, which are determined by the surgeon to be device-related.
Measured: Up to 5 years
Explant
The total number of device explants over the course of follow-up.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start31 Mar 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: Sponsor declined to continue funding the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artivion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Baird, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314868
- Sponsor's protocol ID
- PHF1901.000-M (11/19)
- Acronym
- Retro-C
- Status last verified
- Jan 2023
- First submitted
- 28 Mar 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT05314868
- Acronym / sponsor ID
- Retro-C / PHF1901.000-M (11/19)
- Conditions
- Congenital Heart Disease, Cardiac Anomaly
- Keywords
- bovine pericardium patch, cardiac repair, cardiac reconstruction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor declined to continue funding the study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Artivion Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Device: PhotoFixPediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch.
Key inclusion criteria (1 listed)
- Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium
Key exclusion criteria (1 listed)
- Subject required valve leaflet repair using PhotoFix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotoFixAlso: PhotoFix Decellularized Bovine PericardiumSurgical repair with patch. | Device | Primary cohort |
Primary outcome
Overall survival
Time frame: Up to 5 years
Mortality
4 secondary outcomes
All-cause reoperation
Time frame: Up to 5 years
Device-related reoperation
Time frame: Up to 5 years
Explant
Time frame: Up to 5 years
Morbidity
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Sponsor declined to continue funding the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Baird, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Cardiac Anomaly, run by Artivion Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor declined to continue funding the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.