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GOING BEYOND THE CONVENTIONAL POLARx: Setting a new standard in cryoablation

Going beyond the conventional

POLARx™: Setting a new standard in cryoablation

Clinical Evidence 

Discover results from POLARx™ clinical trials that highlight the benefits of a new cryoablation system

Safety and Outcomes 

POLARICE – 399 AF patients AF registry

In a real-world setting, PVI with POLARx was safe, efficient and effective in experienced cryoballoon centers

OBJECTIVE
Provide real-world data on the use of the POLARx Cryoablation System for the treatment of atrial fibrillation

POLAR ICE (NCT04250714)

  • Prospective
  • Non-randomized
  • Single-arm
  • 19 centers
  • 399 patients
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POLARICE

Safety

3.3% :- Primary safety event rate | 0 :- Number of patients suffered from Atrial Esophageal Fistula Pulmonary Vein Stenosis

Procedural characteristics

Procedural characteristics

Performance and Biophysical 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.

Two cardiac catheter devices.

1-year outcome – Yap et al.

Prospective cohort study, multicenter study, 110 consecutive patients who underwent first‐time cryoballoon ablation to compare the 1-year clinical outcome between POLARx and AFA-Pro (POLARx: n = 57; AFA‐Pro™: n = 53).

Comparison of the 1‑year clinical outcome of a novel cryoballoon​ to an established cryoballoon technology, Yap et al

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Two cardiac catheter devices.

CHARISMA – 10-Month Follow- Up Data

Prospective, non-randomized, multicenter Italian registry to assess safety and effectiveness of POLARx cyoablation system (112 patients, 439 PVs)

Novel cryo-balloon technology for a successful pulmonary vein isolation: acute outcome and follow-up from a large multicenter Italian clinical setting, Fassini et al
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Two cardiac catheter devices.

12-Month Follow-Up Data – Martin et al.

Non-randomized, prospective, multicentre study enrolling 58 consecutive patients to evaluate the long-term safety and efficacy of this novel POLARx cyoablation system in treating Paroxismal AF. (58 patients, 231 PVs)

Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long‑term outcomes in a multicentre clinical study, Martin et al.
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Two cardiac catheter devices.

ANTARTICA study - Christian-H Heeger et al.​

Multicenter assessment of efficacy and safety of the POLARx cryoablation system with a cohort of 317 patients treated for paroxysmal AF.​

Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety ANTARCTICA study. Christian-H Heeger et al
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Biophysical Parameters

Two cardiac catheter devices.

Honarbakhsh et al.

Prospective, multicentre study, included patients that underwent cryoablation for AF. Safety, efficacy, and cryoablation metrics were compared between PolarX and a propensity-matched AFA cohort

POLARx Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation, Honarbakhsh et al

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iacopino et al

Iacopino et al.

Prospective, single-arm, multicenter study, first 69 patients treated with POLARx Cryoablation System. Procedural and acute data was collected on 247 PVs.

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry, Iacopino et at.

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Yap et al.

Prospective cohort study, multicenter study, 110 consecutive patients who underwent first‐time cryoballoon ablation (POLARx: n = 57; AFA‐Pro™: n = 53).

Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: insights from an initial multicenter experience, Yap et al.

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Yap et al.
iacopino et al

Martin et al.

Prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 centers, between Aug 2020 and May 2021. This study included any patients indicated for treatment of PAF with the POLARx cryoablation system.

Biophysical Parameters and Time To Isolation of Pulmonary Veins with a Novel Cryoballoon: results of POLAR ICE Study, Martin et al.
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Head-to-head data

Single-center and multicenter published studies comparing POLARx™ to Artic Front Advance.

Procedural Characteristics

Click below to access the full papers

Yap et al. | Multicenter ²
Kochi et al. | Single Center ³
Creta et al. | Single Center ⁴
Tilz et al. | Single Center ⁵
Mojica et al. | Single center ⁶
Guckel et al | Multicenter ⁷
Imnadze et al | Multicente ⁸
Two cardiac catheter devices.

CE mark data

Non-randomized, single-arm, prospective, multicenter study to assess safety and effectiveness of POLARx cryoablation system in patients undergoing PVI (n=30) for the treatment of paroxysmal AF.

Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience, Ante et al.
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Two cardiac catheter devices.

1-year outcome – Knecht et al.

Non-randomized, prospective, multicentre study enrolling 80 consecutive patients to evaluate the long-term safety and efficacy of POLARx cyoablation system (40 patients) in comparision with AFA Pro cyoablation system in the tratment of paroxysmal atrial fibrillation

Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome, Knecht et al .
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Two cardiac catheter devices.

Yap et al. - New meta analysis​

Multicenter assessment of efficacy and safety of the POLARx cryoablation system with a cohort of 317 patients treated for paroxysmal AF. Systematic review and meta-analysis comparing POLARx and AFA-Pro that provides new safety data on minimal esophageal temperature and thromboembolic events.

Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis​.
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Find publication summaries and key take aways from the latest cryoablation studies.

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Two cardiac catheter devices.

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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.

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This material not intended for use in France.