At a glance
ClinicalIndex Comparison RecordN/ACompleted· 225 enrolled
Drug / intervention
Antiarrhythmic drug +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Symptomatic paroxysmal atrial fibrillation with physician documentation and ECG-documented AF within 6 months
- ✓Age 18–80 years
Key exclusion· 23
- ✕Prior antiarrhythmic drug (AAD) class I or III use, including sotalol, intended to prevent AF recurrence (unless <7 days for conversion)
- ✕History of persistent AF (sustained >7 days or requiring cardioversion after 48 hours)
- ✕Left atrial diameter >5.0 cm
- ✕Prior left atrial ablation or surgical procedure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
In Brief
A clinical study evaluating Cryoablation and Antiarrhythmic drug for Atrial Fibrillation and Atrial Fibrillation New Onset. Completed, enrolled 225 participants across 24 sites.
Detailed Summary
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Fibrillation New Onset
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJun 2017
Primary CompletionJun 2020
TodayJul 2026
First PostedApr 18, 2017
Enrollment StartJun 23, 2017
Primary CompletionJun 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.2 years ago
Interventions
Cryoablationdevice
Pulmonary vein isolation via ablation with cryoballoon catheter
Antiarrhythmic drugdrug
Antiarrhythmic drug initiation