Left Atrial Appendage Exclusion
Conditions
Keywords
left atrial appendage, laa, atrial fibrillation, afib, af, stroke, tia
Brief summary
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
Interventions
Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
Sponsors
AtriCure, Inc.
Study design
Allocation
NON_RANDOMIZED
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 any one of the following risk factors and is thought to benefit from LAA occlusion: * CHADS score \> 2 * Age \> 75 years * Hypertension and age \> 65 years * Previous stroke * History of atrial fibrillation (any classification) 3. Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support. 4. Subject is willing and able to provide written informed consent. 5. Subject has a life expectancy of at least 1 year. 6. Subject is willing and able to return for scheduled follow-up visits.
Exclusion criteria
1. Previous cardiac surgery 2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip. 3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair. 4. NYHA Class IV heart failure symptoms 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) 6. Creatinine \>200 µmol/L 7. LAA is not appropriate for exclusion based on intraoperative evaluations 8. Current diagnosis of active systemic infection 9. Renal failure requiring dialysis or hepatic failure 10. A known drug and/or alcohol addiction 11. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study 12. Pregnancy or desire to get pregnant within 12-months of the study treatment 13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes 14. Patients who have been treated with thoracic radiation 15. Patients in current chemotherapy 16. Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases. 17. Patients with known connective tissue disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device Related Serious Adverse Events | Discharge/30 days Post Procedure | The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study. |
| Percent of Patients With Complete Occlusion of the Left Atrial Appendage. | 3 Months Post Procedure | The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion. |
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).
Participants by arm
| Arm | Count |
|---|---|
| AtriCure LAA Exclusion System AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Missed Visit | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | AtriCure LAA Exclusion System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 62 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 73.1 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 70 |
| serious Total, serious adverse events | 35 / 70 |
Outcome results
Primary
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.
Time frame: 3 Months Post Procedure
Population: The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriCure LAA Exclusion System | Percent of Patients With Complete Occlusion of the Left Atrial Appendage. | 95.1 percentage of subjects |
Primary
Rate of Device Related Serious Adverse Events
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Time frame: Discharge/30 days Post Procedure
Population: The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AtriCure LAA Exclusion System | Rate of Device Related Serious Adverse Events | 0 Number of participants |