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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Cryo Global Registry


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General
Study Status Study Pending
Application Number /
Requirement Number
P100010 S110/ PAS001
Date Original Protocol Accepted 12/16/2021
Date Current Protocol Accepted  
Study Name Cryo Global Registry
Device Name Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, 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


Cryo Global Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/17/2021 12/17/2021 On Time
1 year report 06/18/2022 06/16/2022 On Time
18 month report 12/17/2022    
2 year report 06/18/2023    
3 year report 06/17/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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