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This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.
This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.
The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.
A total of 60 subjects will be enrolled in this study at a single site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Electric cardiac surgery only | |
| Treatment group | Experimental | Elective cardiac surgery plus prophylactic maze procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propylactic maze | Device | Prophylactic limited left sided maze procedure for subjects in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Documented Post-operative Atrial Fibrillation | Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment. | From date of index surgical procedure to date of discharge, on average 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group | the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded | immediately after procedure/surgery up to discharge from the hospital, average 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles L Willekes, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36933787 | Derived | Willekes CL, Fanning JS, Heiser JC, Wai Sang SL, Timek TA, Parker J, Ragagni MK. Randomized feasibility trial of prophylactic radiofrequency ablation to prevent atrial fibrillation after cardiac surgery. J Thorac Cardiovasc Surg. 2024 Jun;167(6):2129-2135.e1. doi: 10.1016/j.jtcvs.2023.03.010. Epub 2023 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Elective cardiac surgery only |
| FG001 | Treatment Group | Elective cardiac surgery plus prophylactic maze procedure prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Elective cardiac surgery only |
| BG001 | Treatment Group | Elective cardiac surgery plus prophylactic maze procedure prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Documented Post-operative Atrial Fibrillation | Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment. | Posted | Count of Participants | Participants | From date of index surgical procedure to date of discharge, on average 1 week. |
|
1 year
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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 | Control Group | Elective cardiac surgery only | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post op Atrial Fibrillation | Cardiac disorders | Afib | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | UTI | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Willekes | Corewell Health | 616-459-7258 | Charles.Willekes@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2020 | Jun 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2021 | Jun 22, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. |
record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal |
| during the procedure/surgery, up to 8 hours |
| Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group | the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded | immediately after procedure/surgery up to discharge from the hospital, on average 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group | the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded | Posted | Count of Participants | Participants | immediately after procedure/surgery up to discharge from the hospital, average 1 week |
|
|
|
| Secondary | Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. | record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal | Posted | Mean | Standard Deviation | percentage of events | during the procedure/surgery, up to 8 hours |
|
|
|
| Secondary | Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group | the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded | Posted | Count of Participants | Participants | immediately after procedure/surgery up to discharge from the hospital, on average 1 week |
|
|
|
| 31 |
| 15 |
| 31 |
| 23 |
| 31 |
| EG001 | Treatment Group | Elective cardiac surgery plus prophylactic maze procedure prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm | 0 | 29 | 12 | 29 | 21 | 29 |
| Acute Kidney Injury/ Acute Renal Failure | Renal and urinary disorders | AKI | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Resp. Failure | Systematic Assessment |
|
| Respiratory Infections/Pneumonia | Respiratory, thoracic and mediastinal disorders | Res. Infection/ Pneu | Systematic Assessment |
|
| Covid 19 | Respiratory, thoracic and mediastinal disorders | Covid-19 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Anemia | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | Atrial flutter | Systematic Assessment |
|
| Hematoma | Vascular disorders | Hematoma | Systematic Assessment |
|
| Thrombotic Event | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| ulcerated aorta | Vascular disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Conduit Issues | Cardiac disorders | Systematic Assessment | angioplasty and stent required post-op; coronary artery occlusion |
|
| PEA Arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Hypertension/systemic | Cardiac disorders | Systematic Assessment |
|
| GI disorders | Gastrointestinal disorders | Systematic Assessment | colitis; ogilvie syndrome |
|
| Miscellaneous | General disorders | Systematic Assessment | cellulitis, deconditioning, lens discoloration, cholecystitis, leg pain, skin melanoma, osteo arthritis |
|
| injury | Injury, poisoning and procedural complications | Systematic Assessment | fall and fracture. |
|
| UTI | Renal and urinary disorders | Systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| neurological disorder | Psychiatric disorders | Systematic Assessment | encephalopathy;delirium |
|
| Dysphagia | Nervous system disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute brain infarct | Vascular disorders | Systematic Assessment |
|
| Carotid Stenosis | Vascular disorders | Systematic Assessment | known pre-op but led to intervention. |
|
| Bone Fracture | Injury, poisoning and procedural complications | Bone fracture | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Hyponatremia | Systematic Assessment |
|
| Confusion/Delerium | Nervous system disorders | Confusion/Delerium | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Resp. Failure | Systematic Assessment |
|
| Contusion | Vascular disorders | Contusion | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Anemia | Systematic Assessment |
|
| Post op Afib | Cardiac disorders | post op Afib | Systematic Assessment |
|
| Elevated Creatine | Renal and urinary disorders | Elevated Creatine | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Bradycardia | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |