Clinical Evidence
Discover results from POLARx™ clinical trials that highlight the benefits of a new cryoablation system
Safety & Efficacy outcomes
FROzEN-AF US IDE Clinical Trial
FROzen AF is a global, prospective, single-arm study, researchers evaluated the safety and effectiveness of the POLARx™ Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF). 385 patients were enrolled across 44 sites; 50 patients in the POLARx FIT arm.
| Procedural Characteristic |
FROzEN-AF (28 mm balloon) |
POLARxᵀᴹ FIT Extension Arm (28 mm / 31 mm balloon) |
| General Anesthesia (%) | 78.5% | 100% |
| Conscious Sedation/MAC (%) | 21.5% | - |
| Procedure Time (min) | 91 ± 41 min |
101 ± 59 min |
| LA Dwell Time (min) | 59 ± 33 min | 51 ± 22 min |
| Fluoroscopy Time (min) | 12.9 ± 11.2 min | 7.2 ± 11.3 min |
| Grade 3-4 Occlusion* (%) | 95.9% (69.9% - Grade 4) | 97.8% (67.3% / 80.8% - Grade 4) |
| Single Shot Success* (%) | 55.9% | 35.3% / 62.1% |
*Only ablations with duration >60S included in ablation counts
Outcomes from FROzEN-AF US IDE Trial
The choice of balloon sizes (31 and 28 mm) with POLARx FIT may assist in overcoming challenges related to variability in patient PV size and geometry with the 31 mm balloon size.
FROZEN AF (POLARx)
*Safety: Including esophageal fistulas, persistent phrenic nerve palsy and PV stenosis
** 28mm/31mm
Extended POLARx FIT arm
- Ellenbogen et al. One-Year Outcomes of Pulmonary Vein Isolation with a Novel Cryoballoon in 325 Patients: Primary Results of the FROzEN-AF Trial. HRS 2023.
- Su et al. Clinial Application of a Novel 31mm Cryoballoon for Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation: Procedural Data from the FIT arm of FROzEN-AF. HRS 2023.
POLAR-ICE
POLAR-ICE is a prospective, non-randomized, single-arm post-market study with 19 participating centers from 7 countries that enrolled 399 patients.
Acute Outcomes from POLAR ICE study
Safety
Procedural characteristics
Performance and Biophysical Characteristics
Acute procedural characteristics, efficacy, and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR-ICE study, Tilz et al.
1-year outcomes from POLAR-ICE study
Long-term outcomes for 399 patients with paroxysmal atrial fibrillation treated through PVI with POLARx Cryoablation Catheter demonstrated high effectiveness and safety.
Lower nadir temperatures and a longer thawing time were predictors of clinical success.
A Luik, oral presentation, ESC 2023 Amsterdam
Procedural & Biophysical parameters
Comparative Performance
Single-center and multicenter published studies comparing POLARx™ to Artic Front Advance.
Click below to access the full papers
References
1. Anic et al. EP Europace, 2021.
2. Yap, S-C, Anic, A, Breskovic, T, et al. Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience. J Cardiovasc Electrophysiol. 2021; 32: 580– 587.
3. Kochi, AN, Moltrasio, M, Tundo, F, et al. Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform. J Cardiovasc Electrophysiol. 2021; 32: 588– 594.
4. Creta, A, Kanthasamy, V, Schilling, RJ, et al. First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison. J Cardiovasc Electrophysiol. 2021; 32: 925- 930.
5. Roland Richard Tilz, Roza Meyer-Saraei, Charlotte Eitel, Thomas Fink, Vanessa Sciacca, Lisbeth Delgado Lopez, Bettina Kirstein, Michael Schlüter, Julia Vogler, Karl-Heinz Kuck, Christian-H. Heeger, Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation ― The Prospective ICE-AGE-X Study ―, Circulation Journal, Article ID CJ-21-0094, Advance online publication April 13, 2021, Online ISSN 1347-4820, Print ISSN 1346-9843, https://doi.org/10.1253/circj.CJ-21-0094, https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-21-0094/_article/-char/en
6. De Asmundis et At. JAfib Jun-Jul 2021, Vol-14 Issue-1.
7. Guckel, D., Lucas, P., Isgandarova, K. et al. Impact of pulmonary vein variant anatomy and cross-sectional orifice area on freedom from atrial fibrillation recurrence after cryothermal single-shot guided pulmonary vein isolation. J Interv Card Electrophysiol (2022). https://doi.org/10.1007/s10840-022-01279-w
8. Guram Imnadze, Thomas Fink, Mustapha El Hamriti, Leonard Bergau, Martin Braun, Moneeb Khalaph, Vanessa Sciacca, Khuraman Isgandarova, Denise Guckel, Christian Sohns, Philipp Sommer. Two competing cryoballoon technologies for single shot pulmonary vein isolation: first experiences with the novel system. Rev. Cardiovasc. Med. 2022, 23(4), 118.
CAUTION:
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