|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P100010 S110/ PAS001 |
| Date Original Protocol Accepted |
12/16/2021
|
| Date Current Protocol Accepted |
03/25/2024
|
| Study Name |
STOP AF First PAS
|
| Device Name |
Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective is to estimate the 36-month freedom from AF/AFL/AT recurrence.
|
| Study Population |
Subjects greater than or equal to 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ Cardiac Cryoablation Catheter System may be approached regarding enrollment in this study.
|
| Sample Size |
Up to 200 subjects will be enrolled to ensure up to 175 subjects are treated.
|
| Key Study Endpoints |
Primary Safety Endpoint
The occurrence of a Primary Safety Event defined as a serious cryoballoon procedure-related or serious cryoballoon system-related AE including the following;
• Transient ischemic attack (within seven days of ablation procedure).
• Cerebrovascular accident (within seven days of ablation procedure).
• Major bleeding that requires transfusion (within seven days of ablation procedure).
• Cardiac perforation, tamponade, or pericardial effusion (within seven days of ablation procedure).
• Pulmonary vein stenosis (> 70% reduction within 6-months of ablation procedure).
• Myocardial infarction (within seven days of ablation procedure).
• Phrenic nerve injury (unresolved at 12-months).
• Atrio-esophageal fistula (within 6-months of ablation procedure).
• Death (within seven days of ablation procedure).
Secondary Safety Endpoint
• Characterize all reported AEs through 36-months.
Main Effectiveness Endpoints
Recurrent AF/AFL/AT recurrence through 36 months (after 90-day blanking period), defined as:
• Documented recurrent AF/AFL/AT on a rhythm monitoring device.
• Repeat ablation for the treatment of AF/AFL/AT.
• Cardioversion for the treatment of AF/AFL/AT.
Secondary Effectiveness Endpoints
• Characterize the cryoablation procedure
• Change in Quality of Life through 36-months
• Estimate the freedom from symptomatic AF/AFL/AT recurrence through 36 months.
• Estimate the freedom from AF/AFL/AT recurrence through 36 months for subjects on/off all Class I/III AADs after the 90-day blanking period.
• Characterize data pre- and post- ablation captured by sensor device
|
| Follow-up Visits and Length of Follow-up |
36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
19
|
| Actual Number of Sites Enrolled |
10
|
