An observational study in Coronary Disease, sponsored by Elutia Inc.. Completed at 43 sites in United States. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Elutia Inc. · Observational
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
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:
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's enrollment of 1,420 is above the median of 460 across 953 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Elutia Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who have received CorMatrix ECM for pericardial reconstruction
Exclusion Criteria:
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
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
| Milestone | CorMatrix ECM |
|---|---|
| Started | 1420 |
| Completed | 1420 |
| Not completed | 0 |
Data will be collected at the initial post-operative visit. This is a single visit study.
| Proportion of subjects | CorMatrix ECM |
|---|---|
| Proportion of Subjects With Device Related Adverse Events. | 0 (0 to 0) |
Collected over Data was collected through the subjects' first follow-up visit, which ranged from 0 to 229 days post-operatively.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CorMatrix ECM | 8/1,420 (0.6%) | 0/1,420 (0%) | 0/1,420 (0%) |
| Age, Categorical(Participants) | CorMatrix ECM |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 845 |
| >=65 years | 575 |
| Age, Continuous(years) | CorMatrix ECM |
|---|---|
| Mean | 61.3 ± 11.9 |
| Sex: Female, Male(Participants) | CorMatrix ECM |
|---|---|
| Female | 376 |
| Male | 1,044 |
| Ethnicity (NIH/OMB)(Participants) | CorMatrix ECM |
|---|---|
| Hispanic or Latino | 118 |
| Not Hispanic or Latino | 1,302 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | CorMatrix ECM |
|---|---|
| American Indian or Alaska Native | 7 |
| Asian | 18 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 158 |
| White | 1,088 |
| More than one race | 141 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | CorMatrix ECM |
|---|---|
| United States | 1,420 |
| Pre-Operative Risk Factors(Risk factors) | CorMatrix ECM |
|---|---|
| Hypertension | 1,138 |
| Hypercholesterolemia | 727 |
| Diabetes Mellitus | 531 |
| Smoking | 357 |
| Prior Myocardial Infarction | 242 |
| Congestive Heart Failure | 226 |
| Chronic Obstructive Pulmonary Disease | 158 |
| Prior Percutaneous Coronary Intervention | 126 |
| Chronic Renal Failure | 70 |
| Prior Cerebrovascular Accident | 60 |
| Index Procedure(Participants) | CorMatrix ECM |
|---|---|
| Isolated CABG | 923 |
| Valve Repair/Replacement | 300 |
| CABG & Valve Repair/Replacement | 136 |
| Other | 61 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Elutia Inc.