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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100046 / PAS001 |
| Date Original Protocol Accepted |
12/14/2011
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| Date Current Protocol Accepted |
06/13/2014
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| Study Name |
AtriCure Synergy Ablation System
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| Device Name |
ATRICURE SYNERGY ABLATION SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, observational, single arm registry study.
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| Study Population |
Subjects who are at least 18 years old, have non-paroxysmal forms of atrial fibrillation, are scheduled to undergo a primary open cardiac surgical procedure requiring cardiopulmonary bypass, including valve surgery, and or coronary artery bypass grafting (CABG), and who do not meet any of the exclusion criteria.
There is no control group
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| Sample Size |
The sample size of 350 subjects obtained from 50 different U.S. sites is driven by the need to test the safety hypothesis, which is that one-month serious device- and procedure-related adverse events will occur in no greater than 10% of the study population. The calculation assumes a one-sided test for statistical significance at the p < 0.05 level, 80% power, an estimated rate of 6.25%, and a maximum of 5% subject attrition at one month, providing a sample size at one month of at least 333 subjects.
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| Key Study Endpoints |
Main Endpoints
Safety: Serious device and procedure-related adverse events (not including pacemaker implantation) at one month post-procedure or during hospitalization for the procedure (whichever is longer). An independent Clinical Events Committee (CEC) will review all reported potential endpoint adverse events that occur within 30 days post-procedure, in order to make a determination on the device- or procedure-relatedness and the seriousness of the AE.
Effectiveness: Freedom from AF (i.e. no episodes lasting > 30 seconds of either atrial fibrillation, atrial flutter, or atrial tachycardia) while off of Class I and III anti-arrhythmic drugs for at least 4 weeks (except amiodarone, which the subject must be off of for 12 weeks prior to assessment), as determined by an independent core lab assessment of 48 hour Holter monitor, Zio Patch, or PPM interrogation recording, at one, two and three years post-procedure.
Secondary Endpoints
Proportion of subjects free from AF regardless of AAD usage, at one, two and three years post-procedure.
Major adverse events within 30 days post-procedure or by hospital discharge, whichever is longer, including:
Death (Included even if greater than 30 days if procedure-related)
Stroke
TIA
Myocardial infarction
Bleeding requiring > 2 units of blood and surgical intervention
Any adverse event
Serious device- and procedure-related adverse event by type of mprimary cardiac surgical procedure
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| Follow-up Visits and Length of Follow-up |
3 years post-procedure
Clinical follow-up will be at 30 days, 4 months, and 1, 2, and 3 years post-procedure. At least three unsuccessful attempts to contact a subject who has missed a clinic visit, by telephone and certified mail, must be made before a subject will be classified as lost to follow-up.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
365 subjects enrolled for this study.
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| Actual Number of Sites Enrolled |
40 sites enrolled for this study.
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| Patient Follow-up Rate |
The follow-up rate is 85.1% (309/363) at 36 months.
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| Final Safety Findings |
1.1% (4/365, [90% CI: 0.4%,2.5%]) subjects experienced 4 serious device or ablation procedure-related adverse events within 30 days post-procedure, which met the primary safety endpoint performance goal (PG) of 10%. All the events were procedure related.
8.8% (32/365) subjects developed a total of 36 acute Major Adverse Events within 30 days post-procedure ( 5.5% (20/365) death, 1.9% (7/365) excessive bleeding, 1.6% (6/365) strokes with significant permanent disability, and 0.8% (3/365) Myocardial Infarction (MI)). No TIA was reported.
A total of 2352 adverse events were reported in 95.1% (347/365) subjects. Of which, 47.1% (1108/2352) of the events reported occurred during the initial hospitalization or within the 30-day follow-up.
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| Final Effect Findings |
The proportion of patients free from AF, off antiarrhythmic drugs was 66.2% [90% CI: 61.2%, 70.9%] at 12 months, 64.9% [90% CI: 59.6%, 70.0%] at 24 months, and 62.9% [90% CI :57.4%, 67.2%]. at 36 months.
The primary effectiveness endpoint PG of 47.8% at 36 months was met.
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| Study Strengths & Weaknesses |
Strength: The ABLATE PAS study evaluated 3-year long term safety and effectiveness of the device. The primary study endpoints were formally evaluated with hypothesis testing and all primary endpoints performance goals were met. Subgroup analysis based on gender, AF type, procedure type, and user experience were provided and did not raise any concerns.
Weakness:
In the statistical analysis plan (SAP), the specific analysis method to evaluate the primary effectiveness endpoint at 36 months was not clearly specified (e.g., calculating either Kaplan-Meier probability rate or proportion of subject free of AF).
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.
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