Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEpropylactic maze
Prophylactic limited left sided maze procedure for subjects in the treatment arm
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective cardiac surgery * AVR * CABG * AVR/CABG
Exclusion criteria
* History of AF/Aflutter * Less common cardiac surgeries: * aortic root replacement * aortic dissections * myxoma * pericardectomies * off-pump procedures * redo procedures * Subjects with existing pacemakers, AICD * Vulnerable population * Emergent surgery * Currently participating in investigational drug or device study. * Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Documented Post-operative Atrial Fibrillation | From date of index surgical procedure to date of discharge, on average 1 week. | Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group | immediately after procedure/surgery up to discharge from the hospital, average 1 week | the utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded |
| Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. | during the procedure/surgery, up to 8 hours | record and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal |
| Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group | immediately after procedure/surgery up to discharge from the hospital, on average 1 week | the utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Elective cardiac surgery only | 31 |
| Treatment Group Elective cardiac surgery plus prophylactic maze procedure
prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Treatment Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 75 years | 75 years | 75 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 29 participants | 60 participants | 31 participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 39 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 23 / 31 | 21 / 29 |
| serious Total, serious adverse events | 15 / 31 | 12 / 29 |
Outcome results
Primary
Incidence of Documented Post-operative Atrial Fibrillation
Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.
Time frame: From date of index surgical procedure to date of discharge, on average 1 week.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Incidence of Documented Post-operative Atrial Fibrillation | 17 Participants |
| Treatment Group | Incidence of Documented Post-operative Atrial Fibrillation | 2 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
Time frame: immediately after procedure/surgery up to discharge from the hospital, average 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group | 14 Participants |
| Treatment Group | Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group | 2 Participants |
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
Time frame: immediately after procedure/surgery up to discharge from the hospital, on average 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group | 7 Participants |
| Treatment Group | Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group | 1 Participants |
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
Time frame: during the procedure/surgery, up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. | 0 percentage of events | Standard Deviation 0 |
| Treatment Group | Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation. | 0 percentage of events | Standard Deviation 0 |