Over 8’500 AF patients treated with Medtronic ablation therapies across more than 40 centers.
The 1STOP Initiative
1STOP (One Shot to PVI) is a large-scale, real-world data initiative capturing clinical insights from over 8'500 patients across more than 47 hospitals in Italy. It focuses on patients undergoing cardiac ablation using Medtronic’s Cardiac Ablation Solutions, including the Arctic Front™ family of cryoablation catheters and, more recently, the PulseSelect™ pulsed field ablation (PFA) system, and the Affera™ Mapping and Ablation system.
The initiative is designed to improve patient outcomes by collecting, managing, analyzing, and reporting treatment data - sometimes supported through the dedicated patient app, MyCryo App. To date, 1STOP has supported over 20 scientific publications, exploring key topics such as:
- Acute outcomes, procedural efficiency, and safety of pulsed field ablation (PFA)
- Learning curve and clinical adoption of the PulseSelect™ PFA system
- Comparative performance of cryoballoon generations
- Cryoablation outcomes across diverse patient risk profiles
- Cryoablation by indication: first-line, redo, persistent, and paroxysmal AF
- Early intervention strategies
- Techniques to optimize patient outcomes
- Imaging and time-to-isolation measurements
PulseSelect pulsed field ablation system
Data on pulsed field ablation (PFA) using the PulseSelect™ PFA system, is actively being collected within the 1STOP initiative. This section will continue to be updated as additional clinical insights and outcomes become available.
Acute outcomes and learning curve from the initial patients treated with the PulseSelect system: a real‑world multicenter experience of pulsed field ablation
Molon et al. 2025, Journal of Interventional Cardiac
Use of the PulseSelect PFA system in treating paroxysmal and persistent atrial fibrillation (AF) demonstrated short procedural times, a rapid learning curve, high acute procedural efficiency, and a favourable safety profile with no major complications observed. General anaesthesia was not needed in approximately one out of four cases.
Comparing generations of Arctic Front™ Cryoballoon
Second versus fourth generation of cryoballoon catheters
Manfrin et al., 2022, Pacing and Clinical Electrophysiology, (No = 429)
Usage of the fourth generation Arctic Front cryoballon family™ increased the rate of acute PVI recording capability and resulted in a higher rate of long-term PVI success, as demonstrated by the reduced rate of AF recurrence in comparison to the 2nd generation cohort at the 12-month follow-up period.
A comparison of acute procedural outcomes within four generations of cryoballoon catheters
Iacopino et al., 2019, Journal of Cardiovascular Electrophysiology, (No = 480)
The Arctic Front cryoballon family™ achieved significantly faster procedural ablation times in comparison to the previous generations, while still maintaining a low rate of acute complications. Also, the rate of TTI visualization was observed to be higher with the last catheter’s generation.
The data is owned by the hospital centers and is processed by Medtronic in accordance with current regulations on data processing in pseudonymized form to enable the provision of the service.
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