Trial Outcomes & Findings for Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery (NCT NCT03604432)
NCT ID: NCT03604432
Last Updated: 2023-11-07
Results Overview
Per the STS registry definition of occurrence of postoperative atrial fibrillation that requires treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
From date of index surgical procedure to date of discharge, on average 1 week.
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Control Group
Elective cardiac surgery only
|
Treatment Group
Elective cardiac surgery plus prophylactic maze procedure
prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=31 Participants
Elective cardiac surgery only
|
Treatment Group
n=29 Participants
Elective cardiac surgery plus prophylactic maze procedure
prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
n=31 Participants
|
75 years
n=29 Participants
|
75 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=31 Participants
|
14 Participants
n=29 Participants
|
21 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=31 Participants
|
15 Participants
n=29 Participants
|
39 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
29 participants
n=29 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=31 Participants
Elective cardiac surgery only
|
Treatment Group
n=29 Participants
Elective cardiac surgery plus prophylactic maze procedure
propylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Incidence of Documented Post-operative Atrial Fibrillation
|
17 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: immediately after procedure/surgery up to discharge from the hospital, average 1 weekthe utilization of antiarrhythmic medication required to manage postoperative atrial fibrillation will be recorded
Outcome measures
| Measure |
Control Group
n=31 Participants
Elective cardiac surgery only
|
Treatment Group
n=29 Participants
Elective cardiac surgery plus prophylactic maze procedure
propylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group
|
14 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: during the procedure/surgery, up to 8 hoursrecord and describe any patient related morbidity or adverse outcome related to the radiofrequency pulmonary vein isolation or left atrial appendage removal
Outcome measures
| Measure |
Control Group
n=31 Participants
Elective cardiac surgery only
|
Treatment Group
n=29 Participants
Elective cardiac surgery plus prophylactic maze procedure
propylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.
|
0 percentage of events
Standard Deviation 0
|
0 percentage of events
Standard Deviation 0
|
SECONDARY outcome
Timeframe: immediately after procedure/surgery up to discharge from the hospital, on average 1 weekthe utilization of anticoagulant medications required to manage postoperative atrial fibrillation will be recorded
Outcome measures
| Measure |
Control Group
n=31 Participants
Elective cardiac surgery only
|
Treatment Group
n=29 Participants
Elective cardiac surgery plus prophylactic maze procedure
propylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group
|
7 Participants
|
1 Participants
|
Adverse Events
Control Group
Serious events: 15 serious events
Other events: 23 other events
Deaths: 0 deaths
Treatment Group
Serious events: 12 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=31 participants at risk
Elective cardiac surgery only
|
Treatment Group
n=29 participants at risk
Elective cardiac surgery plus prophylactic maze procedure
prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Cardiac disorders
Post op Atrial Fibrillation
|
19.4%
6/31 • Number of events 6 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury/ Acute Renal Failure
|
9.7%
3/31 • Number of events 3 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
12.9%
4/31 • Number of events 4 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infections/Pneumonia
|
9.7%
3/31 • Number of events 3 • 1 year
|
0.00%
0/29 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Covid 19
|
3.2%
1/31 • Number of events 1 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • Number of events 1 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/31 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Vascular disorders
Hematoma
|
0.00%
0/31 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Thrombotic Event
|
3.2%
1/31 • Number of events 1 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Vascular disorders
ulcerated aorta
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/29 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/29 • 1 year
|
|
Cardiac disorders
Conduit Issues
|
0.00%
0/31 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Cardiac disorders
PEA Arrest
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hypertension/systemic
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
GI disorders
|
6.5%
2/31 • Number of events 2 • 1 year
|
0.00%
0/29 • 1 year
|
|
General disorders
Miscellaneous
|
12.9%
4/31 • Number of events 5 • 1 year
|
3.4%
1/29 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
injury
|
3.2%
1/31 • Number of events 1 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
UTI
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Psychiatric disorders
neurological disorder
|
6.5%
2/31 • Number of events 2 • 1 year
|
0.00%
0/29 • 1 year
|
|
Nervous system disorders
Dysphagia
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/31 • 1 year
|
3.4%
1/29 • Number of events 1 • 1 year
|
|
Vascular disorders
Acute brain infarct
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/29 • 1 year
|
|
Vascular disorders
Carotid Stenosis
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/29 • 1 year
|
Other adverse events
| Measure |
Control Group
n=31 participants at risk
Elective cardiac surgery only
|
Treatment Group
n=29 participants at risk
Elective cardiac surgery plus prophylactic maze procedure
prophylactic maze: Prophylactic limited left sided maze procedure for subjects in the treatment arm
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
9.7%
3/31 • Number of events 3 • 1 year
|
0.00%
0/29 • 1 year
|
|
Injury, poisoning and procedural complications
Bone Fracture
|
6.5%
2/31 • Number of events 2 • 1 year
|
0.00%
0/29 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.9%
4/31 • Number of events 4 • 1 year
|
37.9%
11/29 • Number of events 11 • 1 year
|
|
Nervous system disorders
Confusion/Delerium
|
12.9%
4/31 • Number of events 4 • 1 year
|
0.00%
0/29 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
9.7%
3/31 • Number of events 3 • 1 year
|
27.6%
8/29 • Number of events 8 • 1 year
|
|
Vascular disorders
Contusion
|
6.5%
2/31 • Number of events 2 • 1 year
|
0.00%
0/29 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
2/31 • Number of events 2 • 1 year
|
10.3%
3/29 • Number of events 3 • 1 year
|
|
Cardiac disorders
Post op Afib
|
38.7%
12/31 • Number of events 12 • 1 year
|
0.00%
0/29 • 1 year
|
|
Renal and urinary disorders
Elevated Creatine
|
0.00%
0/31 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/31 • 1 year
|
6.9%
2/29 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place