At a glance
ClinicalIndex Comparison RecordN/ACompleted· 402 enrolled
Drug / intervention
Medtronic Arctic Front® Cardiac CryoAblation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
In Brief
A clinical study evaluating Medtronic Arctic Front® Cardiac CryoAblation System for Paroxysmal Atrial Fibrillation (PAF). Completed, enrolled 402 participants across 39 sites in 2 countries.
Detailed Summary
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation (PAF)
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartJun 2012
Primary CompletionNov 2017
TodayJul 2026
First PostedOct 21, 2011
Enrollment StartJun 26, 2012
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.7 years ago
Interventions
Medtronic Arctic Front® Cardiac CryoAblation Systemdevice
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.