STOP AF First Post-Approval Study
ConditionParoxysmal Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Ablation Solutions
About this trial
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has been diagnosed with symptomatic paroxysmal AF
Subject is ≥ 18 years of age or minimum age as required by local regulations
Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.
Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Disqualifiers
Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of <4 weeks prior to the index PVI procedure)
Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation
A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.
Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
Trial population
Subjects ≥ 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Arctic Front™ Cardiac Cryoablation Catheter
DevicePulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.
Time frame
36 months2
Freedom from Primary Safety Events
Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov