Coronary Disease
Conditions
Keywords
Open heart surgery, cardiac repair
Brief summary
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
Detailed description
Up to 100 clinical sites will enroll subjects who have received CorMatrix ECM for pericardial reconstruction. The following clinical data will be collected at a single post-operative visit: * Demographic information * Pre-operative risk factors * Surgical procedure * Blood transfusion information, if applicable * Chest tube placement information * Surgical complications * Use of anticoagulation medication * Cardiac related procedures since surgical procedure * Device related adverse events
Interventions
None listed
Sponsors
Elutia Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects who have received CorMatrix ECM for pericardial reconstruction * Sign an Informed Consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Device Related Adverse Events. | Post-op visit, after an average of 30 days | Data will be collected at the initial post-operative visit. This is a single visit study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CorMatrix ECM Data collection for information on the use of CorMatrix ECM for pericardial reconstruction | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | CorMatrix ECM |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 575 Participants |
| Age, Categorical Between 18 and 65 years | 845 Participants |
| Age, Continuous | 61.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 118 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1,302 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Index Procedure CABG & Valve Repair/Replacement | 136 Participants |
| Index Procedure Isolated CABG | 923 Participants |
| Index Procedure Other | 61 Participants |
| Index Procedure Valve Repair/Replacement | 300 Participants |
| Pre-Operative Risk Factors Chronic Obstructive Pulmonary Disease | 158 Risk factors |
| Pre-Operative Risk Factors Chronic Renal Failure | 70 Risk factors |
| Pre-Operative Risk Factors Congestive Heart Failure | 226 Risk factors |
| Pre-Operative Risk Factors Diabetes Mellitus | 531 Risk factors |
| Pre-Operative Risk Factors Hypercholesterolemia | 727 Risk factors |
| Pre-Operative Risk Factors Hypertension | 1,138 Risk factors |
| Pre-Operative Risk Factors Prior Cerebrovascular Accident | 60 Risk factors |
| Pre-Operative Risk Factors Prior Myocardial Infarction | 242 Risk factors |
| Pre-Operative Risk Factors Prior Percutaneous Coronary Intervention | 126 Risk factors |
| Pre-Operative Risk Factors Smoking | 357 Risk factors |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 158 Participants |
| Race (NIH/OMB) More than one race | 141 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 1,088 Participants |
| Region of Enrollment United States | 1,420 participants |
| Sex: Female, Male Female | 376 Participants |
| Sex: Female, Male Male | 1,044 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 1,420 |
| other Total, other adverse events | 0 / 1,420 |
| serious Total, serious adverse events | 0 / 1,420 |
Outcome results
Primary
Proportion of Subjects With Device Related Adverse Events.
Data will be collected at the initial post-operative visit. This is a single visit study.
Time frame: Post-op visit, after an average of 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorMatrix ECM | Proportion of Subjects With Device Related Adverse Events. | 0 Proportion of subjects |