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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P100010 S098/ PAS001 |
| Date Original Protocol Accepted |
02/11/2021
|
| Date Current Protocol Accepted |
|
| Study Name |
STOP Persistent AF PAS
|
| Device Name |
Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
|
| Clinical Trial Number(s) |
NCT03012841
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-center prospective new enrollment study utilizing a sponsor-led registry to estimate the 36-month freedom from Atrial Fibrillation recurrence in patients treated with the Arctic Front Cryoablation system for Persistent Atrial Fibrillation.
|
| Study Population |
Patients at sites participating in Medtronic’s Cryoablation Registry, who are 18 years of age or older and are recommended for ablation with the Artic Front Cardiac Cryoablation Catheter System for treatment of persistent atrial fibrillation.
|
| Sample Size |
Up to 400 subjects will be enrolled in the study to obtain a minimum sample size of 355 patients treated. This sample size was determined to ensure sufficient statistical precision around the three-estimate of treatment effectiveness.
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| Key Study Endpoints |
The Primary Effectiveness endpoint will be freedom from recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia at 36-months post treatment.
The Primary Safety Endpoint is the severe adverse event rate through 12-months post-procedure.
Additional endpoints will: characterize the cryoablation procedure in terms of acute procedural success, time in the cath lab, duration of procedure, duration of fluoroscopy, etc. The change in Quality of Life from baseline through 36 months will be estimated using the EuroQoL five-dimension questionnaire. All adverse events occurring through 36-months will also be summarized.
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed for up to 36-months post-procedure.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
27.2% of subjects experienced an adverse event, 24.3% of subjects considered serious adverse events. 2.1% of subjects experienced a device-related adverse event, 1.3% of subjects experienced a serious device-related adverse event. One subject death occurred that was not related to the study procedure
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| Actual Number of Patients Enrolled |
248
|
| Actual Number of Sites Enrolled |
17
|
| Patient Follow-up Rate |
78.3% follow-up completion at 12 months
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