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This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites in the U.S.
The objective of this prospective clinical trial is to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to subjects who did not undergo pericardial closure. Safety will be established by demonstrating that the composite clinical event rate for the ECM treatment group is not worse than the control group that did not undergo pericardial closure. The efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ECM treatment group as compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CorMatrix ECM for Pericardial Closure | Experimental | Pericardial closure with CorMatrix ECM |
|
| Control | No Intervention | No Pericardial Closure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorMatrix ECM for Pericardial Closure | Device | Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:
| 30 days postprocedure |
| Primary Effectiveness Endpoint | Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner. | 7 days postoperatively or hospital discharge, whichever is sooner |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Gerdisch, M.D. | St. Francis Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Medical Center | Birmingham | Alabama | 35213 | United States | ||
| Southeast Alabama Medical Center |
One subject, Subject 011-006, was randomized in error to the ECM treatment group, but did not provide informed consent. This deviation was discovered prior to the surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | CorMatrix® ECM® | CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dothan |
| Alabama |
| 36301 |
| United States |
| Mobile Infirmary Medical Center | Mobile | Alabama | 36607 | United States |
| Providence Hospital | Mobile | Alabama | 36608 | United States |
| Saint Agnes Medical Center | Fresno | California | 93720 | United States |
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| St. Vincent's Hospital | Jacksonville | Florida | 32204 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Saint Francis Heart Center | Indianapolis | Indiana | 46237 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
Pericardium is not closed
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CorMatrix® ECM® | CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure |
| BG001 | Control | No closure of pericardium |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Primary Safety Endpoint | A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:
| Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment. | Posted | Number | percentage of participants | 30 days postprocedure |
|
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| |||||||||||||||||||||||||||||
| Primary | Primary Effectiveness Endpoint | Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner. | Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial. | Posted | Number | percentage of participants | 7 days postoperatively or hospital discharge, whichever is sooner |
|
|
2 years
The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
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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 | CorMatrix ECM for Pericardial Closure | 76 | 208 | 190 | 208 | ||
| EG001 | Control | Pericardium is not closed | 54 | 220 | 189 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Event led to Death | General disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA SOC | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA SOC | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA SOC | Non-systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA SOC | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Cardiomegaly | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Generalised oedema | General disorders | MedDRA SOC | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA SOC | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA SOC | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA SOC | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA SOC | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
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| Incision site infection | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA SOC | Non-systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA SOC | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA SOC | Non-systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA SOC | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA SOC | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA SOC | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA SOC | Non-systematic Assessment |
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If a multi-site publication is not submitted within twenty-four (24) months after conclusion of the Study at all sites, Institution and/or the Principal Investigator may publish the results from Institution's site individually, subject to Sponsor's rights
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | CorMatrix Cardiovascular | 240-247-1170 | clinical@aziyo.com |
| Male |
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