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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CorMatrix ECM | Data collection for information on the use of CorMatrix ECM for pericardial reconstruction |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Device Related Adverse Events. | Data will be collected at the initial post-operative visit. This is a single visit study. | Post-op visit, after an average of 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have received CorMatrix ECM for pericardial reconstruction
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Green | Elutia Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cario-Thoracic Surgeons, P.C. | Birmingham | Alabama | 35243 | United States | ||
| Cardiovascular Consultants, LTD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30876459 | Derived | Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CorMatrix ECM | Data collection for information on the use of CorMatrix ECM for pericardial reconstruction |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2014 | Sep 10, 2019 |
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| Glendale |
| Arizona |
| 85308 |
| United States |
| Phoenix Cardiac Surgery | Phoenix | Arizona | 85016 | United States |
| Southwest Heart & Lung | Phoenix | Arizona | 85028 | United States |
| University of Arizona Medical Center | Tucson | Arizona | 85724 | United States |
| Mercy Clinic Cardiac Thoracic & Vascular Surgery | Fort Smith | Arkansas | 72903 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72205 | United States |
| Baptist Medical Center | Little Rock | Arkansas | 72205 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Heart & Lung Surgical Specialties | Rancho Mirage | California | 92270 | United States |
| Stockton Cardiothoracic Surgical Medical Group | Stockton | California | 95204 | United States |
| Hartford Healthcare Medical Group | Hartford | Connecticut | 06106 | United States |
| Tenet Florida Physician Services | Delray Beach | Florida | 33484 | United States |
| South Florida Heart & Lung Institute | Doral | Florida | 33166 | United States |
| Cardiothoracic & Vascular Surgical Associates | Jacksonville | Florida | 32207 | United States |
| David L. Galbut, MD & Associates | Miami | Florida | 33137 | United States |
| Palm Beach Gardens Medical Center | Palm Beach Gardens | Florida | 33410 | United States |
| Coastal Cardiovascular Surgeons | Panama City | Florida | 32401 | United States |
| Southern Cardiac & Vascular Associates | Tallahassee | Florida | 32308 | United States |
| Cardio Thoracic Vascular Surgery | Macon | Georgia | 31201 | United States |
| Community Health Network | Indianapolis | Indiana | 46250 | United States |
| Reid Hospital | Richmond | Indiana | 47374 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | United States |
| Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research | Kalamazoo | Michigan | 49048 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Magnolia Regional | Corinth | Mississippi | 38834 | United States |
| Baptist Cardiovascular Surgery | Jackson | Mississippi | 39202 | United States |
| St. Peter's Health Partners | Albany | New York | 12208 | United States |
| Triad Cardiac & Thoracic Surgeons | Greensboro | North Carolina | 27401 | United States |
| Wake Medical | Raleigh | North Carolina | 27610 | United States |
| Coastal Thoracic Surgical Associates | Wilmington | North Carolina | 28401 | United States |
| Novant Health Cardiothoracic Surgeons | Winston-Salem | North Carolina | 27104 | United States |
| TriStar Cardiovascular Surgery | Nashville | Tennessee | 37203 | United States |
| Advanced Cardiovascular & Thoracic Surgery | Nashville | Tennessee | 37207 | United States |
| Cardiothoracic & Vascular Surgeons, PA | Austin | Texas | 78756 | United States |
| Cardiothoracic Associates | Corpus Christi | Texas | 78404 | United States |
| Tung H. Cai, MD, PA | Denton | Texas | 76210 | United States |
| KPS Cardiovascular Surgery | Shenandoah | Texas | 77381 | United States |
| Mountain Star Cardiovascular Services, LLC | Salt Lake City | Utah | 84124 | United States |
| Carilion Cardiothoracic Surgery | Roanoke | Virginia | 24014 | United States |
| Thoracic & Cardiovascular Associates, Inc. | Charleston | West Virginia | 25304 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CorMatrix ECM | Data collection for information on the use of CorMatrix ECM for pericardial reconstruction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Pre-Operative Risk Factors | Number | Risk factors |
| |||||||||||||||||||||||
| Index Procedure | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | Proportion of subjects | Post-op visit, after an average of 30 days |
|
|
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Data was collected through the subjects' first follow-up visit, which ranged from 0 to 229 days post-operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CorMatrix ECM | Data collection for information on the use of CorMatrix ECM for pericardial reconstruction | 8 | 1,420 | 0 | 1,420 | 0 | 1,420 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Aziyo Biologics, Inc. | 510-730-7973 | clinical@aziyo.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Diabetes Mellitus |
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| Smoking |
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| Prior Myocardial Infarction |
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| Congestive Heart Failure |
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| Chronic Obstructive Pulmonary Disease |
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| Prior Percutaneous Coronary Intervention |
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| Chronic Renal Failure |
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| Prior Cerebrovascular Accident |
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| CABG & Valve Repair/Replacement |
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| Other |
|