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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100010 / PAS001 |
| Date Original Protocol Accepted |
12/17/2010
|
| Date Current Protocol Accepted |
08/31/2016
|
| Study Name |
STOP AF PAS
|
| Device Name |
ARCTIC FRONT CRYOCATHETER SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
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| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| 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, one-armed, multi-center, non-randomized study.
|
| Study Population |
Patients included in this study will have:
A diagnosis of paroxysmal atrial tachycardia, with at least two episodes of atrial fibrillation in the past three months, at least one which is documented with a tracing
Age 18 and above.
Failure of treatment of atrial fibrillation (AF) with at least one drug indicated for the treatment of paroxysmal atrial fibrillation (PAF)
Presence of no exclusion criteria
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| Sample Size |
370 enrolled with procedure attempts at 30 new user investigational sites and up to 15 STOP AF/continued access protocol AF sites with at least 70% of subject enrollment in the study come from the new user sites
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| Key Study Endpoints |
Cryoablation procedure events and chronic treatment failure at 3 years, and major adverse atrial fibrillation events.
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| Follow-up Visits and Length of Follow-up |
The length of follow-up will be three years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
402 subjects. Modified intent-to-treat (mITT) cohort was comprised of 354 subjects that met all eligibility criteria and were treated per protocol. The primary analysis was conducted in this cohort
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| Actual Number of Sites Enrolled |
39 sites
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| Patient Follow-up Rate |
The follow-up for the mITT cohort was 84% (298/354) at 3 years.
Overall ECG visit compliance was 95.2% and overall Holter visit compliance was 91.3% in mITT subjects.
The mean number of Holter monitors collected per subject was 3.33 across all 354 mITT subjects.
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| Final Safety Findings |
Primary safety endpoint:
-The rate of subjects experiencing one or more cryoablation procedure events (CPE) through 12 months was 2.3% (95% confidence interval (CI): 1.1% - 4.5%), which met the performance goal (PG) of 14.8%.
Secondary safety endpoint:
-The proportion of patients free of major adverse atrial fibrillation (AF) events (MAFE) were (Kaplan-Meier Rate [95% CI]): 90.3% [ 86.6% - 92.9%] , 83.2% [ 78.8% - 86.8%], and 77.8% [ 72.9% - 81.9%], at 1, 2, and 3 years, respectively. The majority of the MAFEs were due to AF recurrence or ablation (69 events in 60 subjects).
MAFE component results ([subjects with events]/354]):
-Cardiovascular death: 0% [0]
-Myocardial infarction: 0.6% [2]
-Stroke 0.3% [1]
-Hospitalization for (primary reason):
*AF recurrence or ablation: 17% [60]
*Atrial flutter ablation (excluding Type I): 4% [14]
*Systemic embolization (not stroke): 0% [0]
*Congestive heart failure: 0.6% [2]
*Hemorrhagic event (not stroke): 1.1% [4]
|
| Final Effect Findings |
Primary effectiveness endpoint
The proportion of subjects free of chronic treatment failure for paroxysmal atrial fibrillation at 36 months was 66.9% (95% CI: 61.6% - 71.7%), which met the PG of 45%.
The proportion of subjects with single procedure success at 36 months was 65.5% (95% CI: 60.1% – 70.3%).
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| Study Strengths & Weaknesses |
Strengths: These results provide further evidence of the long-term (3-year) performance and safety of this device. In this Post Approval Study (PAS), the Arctic Front Cardiac CryoAblation Catheter met both its primary effectiveness endpoint (PG: 45%; the lower bound of the 95% CI: 61.6%) and primary safety endpoint by a good margin (PG: 14.8%; upper bound of the 95% CI: 4.5%). This PAS had a low attrition rate (~16%) at 3 years and very good ECG and Holter visits’ compliance (>90%).
Subject’s follow-up in this PAS was reduced from 5 years to 3 years in 2016. The justification for this reduction in follow-up was (1) the 3-year follow-up being in line with the minimum follow-up duration recommended in the 2012 Heart Rhythm Society Expert Consensus Statement on AF Ablation for the assessment of long term success, (2) no new safety or effectiveness concerns were shown in the PAS data at the time of the protocol review, and (3) the PAS was demonstrating more favorable results than the pivotal study and meeting primary endpoints with a great margin.
Weakness: There was no control group enrolled in this study.
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| Recommendations for Labeling Changes |
This PAS provided important new information about the effectiveness and safety of the device. A labeling update is recommended to include the 3-year data for this device.
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