TRUSTED BY YOU, TRUSTED FOR A REASON.
Arctic Front™
Cardiac Cryoablation
Catheter System
Use the proven solution with confidence3
NOW FDA APPROVED FOR PERSISTENT AF
Arctic Front™ Cardiac Cryoablation Catheter System (hereafter cryoballoon), already CE marked for AF ablation in Europe, is the first1 FDA approved catheter system for persistent AF ablation in the US2.
The expanded FDA approval for persistent AF was based on a subset of STOP Persistent AF trial patients treated in the US1.
Results confirm PVI with the Medtronic Arctic Front Advance™ is safe, effective, and efficient for treating persistent AF and significantly improves patient quality of life, reduces AF-related symptoms, and provides a high rate of freedom from repeat ablation3.
Comparing STOP Persistent AF trial results with CRYO4PERSISTENT AF trial results - (05:48)
Learnings in persistent AF treatment
Prof. Ehrlich´s perspective - (02:25)
Prof. Boveda's perspective - (03:13)
Click below to read the STOP Persistent AF trial results.
Treating Persistent Atrial Fibrillation
According to the new 2020 European Society of Cardiology (ESC) guidelines the complete isolation of the pulmonary veins (PVI) remains the cornerstone of all atrial fibrillation (AF) ablation procedures, including symptomatic persistent AF treatment - now with the highest class of recommendation and level of evidence (class I, level A)4.
Cryoballoon ablation with the Arctic Front™ Cardiac Cryoablation Catheter System is a global standard for AF treatment4.
Results from the European CRYO4PERSISTENT AF trial and the US STOP PERSISTENT AF trial confirm PVI with the Medtronic Arctic Front Advance™ cardiac cryoablation catheter (hereafter “cryoballoon”) is safe, effective, and efficient for treating persistent AF and significantly improves patient quality of life, reduces AF-related symptoms, and provides a high rate of freedom from repeat ablation3,5.
A growing body of evidence also suggests that the time interval between the first diagnosis of AF and catheter ablation has a strong association with the ablation outcomes and markers of atrial remodeling6,7.
CRYO4PERSISTENT Clinical Trial5
Trial Design
CRYO4PERSISTENT is the first prospective, multi-center, single arm study designed to assess the single procedure outcomes of PVI using Arctic Front Advance™ Cryoballoon in patients with symptomatic persistent AF. The trial included 101 patients at 11 sites in Europe (France, Germany, and Greece).
101 patients met inclusion/exclusion criteria, demonstrated 100% AF burden, were treated per the defined protocol, and were included in the primary analysis.
Primary & Secondary Outcomes
Primary outcomes:
Cryoballoon ablation is a short, predictable and effective treatment for this cohort of persistent AF patients, with 60.7% freedom from all atrial arrhythmias at 12 months.
Secondary outcomes:
Cryoballoon ablation had a low complication rate of 4% with no long term clinical sequela and no PNI at discharge.
Patients treated with the Cryoballoon demonstrated a clinically significant improvement in arrhythmia-related symptoms and quality of life, from baseline to 12 months post-ablation.
Quality of Life and Symptom Reduction
The CRYO4PERSISTENT trial demonstrated that persistent AF patients treated with Cryoballoon had a clinically significant improvement in arrhythmia-related symptoms and QOL from baseline to 12 months post-ablation.
US STOP PERSISTENT AF CLINICAL TRIAL3
Trial Design
The US STOP Persistent AF trial is the first and largest prospective, multicenter, single-arm study with pre-defined performance goals to assess the safety and efficacy of PVI only using the Arctic Front Advance™ Cryoballoon to treat patients with drug refractory, symptomatic, persistent AF.
The STOP Persistent AF trial included 165 patients who were treated at 25 sites in the United States, Canada, and Japan.
OUTCOMES
PRIMARY SAFETY ENDPOINT MET
Low Complication Rate | 0.6%
Only one primary safety event, unrelated to study device, occurred in one patient during a repeat ablation procedure.
PRIMARY EFFICACY ENDPOINT MET | 54.8%
Freedom from Atrial Arrhythmia Recurrence 12 Months Post-ablation
- Arctic Front AdvanceTM Cryoballoon PVI only
- Freedom from atrial arrhythmia recurrence (AF/AT/AFL) ≥ 30 seconds and repeat ablation after 90-day blanking period
- No Class I or III AAD initiation or dose increase after blanking period
QUALITY OF LIFE
Significant improvements in quality of life and reduced symptoms by 12 months post-ablation with an 86.8% rate of freedom from repeat ablation.
RESOURCES
References
1
Status June 2020, Medtronic Data on File [Arctic Front™ Cardiac Cryoablation Catheter System is the first FDA approved catheter system for paroxysmal and persistent AF Ablation in the US].
2
This applies to US only. In EMEA the Arctic Front Cardiac Cryoablation Catheter System is indicated for the treatment of patients with atrial fibrillation.
3
Su WW, Reddy VY, Bhasin K, et al. Cryoballoon Ablation of Pulmonary Veins for Persistent Atrial Fibrillation: Results From the Multicenter STOP Persistent AF Trial.Heart Rhythm. Published online June 23, 2020.
4
Hindricks G, Potpara T, Dagres N et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with EACTS, European Heart Journal 2020.
5
Boveda S, Metzner A, Nguyen D, et al. Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation, JACC 2018.
6
Kato T, et al. Circ J (2004) 68: 568
7
Hussein et al. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003669
*
The commercial name of the Medtronic cryoballoon is Arctic FrontTM Cardiac Cryoablation Catheter System.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.