Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, af, ablation, arrhythmia, racing heart, afib, surgical ablation
Brief summary
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
Interventions
DEVICEAtriCure Bipolar System
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is greater than or equal to 18 years of age 2. Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines 3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: * Mitral valve repair or replacement * Aortic valve repair or replacement * Tricuspid valve repair or replacement * Coronary Artery Bypass procedures * Atrial Septal Defect Repair * Patent Foramen Ovale closure 4. Subject's Left Ventricular Ejection Fraction ≥ 30% 5. Subject is able and willing to provide written informed consent and comply with study requirements 6. Subject has life expectancy of at least 1 year
Exclusion criteria
1. Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure 2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure 3. Wolff-Parkinson-White syndrome 4. Prior cardiac surgery (Redo) 5. Class IV NYHA heart failure symptoms 6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit 7. Documented MI within 6 weeks prior to study enrollment 8. Need for emergent cardiac surgery (i.e. cardiogenic shock) 9. Known carotid artery stenosis greater than 80% 10. LA size greater than or equal to 8cm 11. Current diagnosis of active systemic infection 12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion 13. Pregnancy or desire to get pregnant within 12-months of the study enrollment 14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes 15. Renal failure requiring dialysis or hepatic failure 16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia 17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. | 6 Months Post Procedure | — |
| Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | 30 days Post Procedure | Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events. |
Secondary
| Measure | Time frame |
|---|---|
| Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months. | 6 Months Post Procedure |
| Composite 6-month Post-procedure Major Adverse Event Rate. | 6 Months Post Procedure |
Countries
United States
Participant flow
Recruitment details
Treatment subjects were recruited from the routine clinical referral base of one or more surgeons at each investigational site.
Pre-assignment details
Subjects were screened for enrollment and consented prior to being brought to the OR with the potential that they may not be eligible based on some criteria evaluated in OR (i.e. left atrial size assessed by TEE). 1 subject was found to have LA size that excluded them from the trial.
Participants by arm
| Arm | Count |
|---|---|
| AtriCure Bipolar System The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AtriCure Bipolar System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age Continuous | 70.5 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 55 |
| serious Total, serious adverse events | 45 / 55 |
Outcome results
Primary
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
Time frame: 30 days Post Procedure
Population: Safety was evaluated in all subjects enrolled and treated with the device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriCure Bipolar System | Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | 9.1 percentage of subjects |
Primary
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Time frame: 6 Months Post Procedure
Population: The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriCure Bipolar System | Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. | 74 percentage of subjects |
Secondary
Composite 6-month Post-procedure Major Adverse Event Rate.
Time frame: 6 Months Post Procedure
Population: Safety was evaluated in all subjects enrolled and treated with the device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriCure Bipolar System | Composite 6-month Post-procedure Major Adverse Event Rate. | 10.9 percentage of subjects |
Secondary
Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
Time frame: 6 Months Post Procedure
Population: The analysis population included subjects that were evaluable for the Secondary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriCure Bipolar System | Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months. | 84 percentage of subjects |