GOING BEYOND THE CONVENTIONAL
POLARx™: Setting a new standard in cryoablationDiscover results from POLARx™ clinical trials that highlight the benefits of a new cryoablation system
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
Safety
3.3%
Primary Safety Event Rate
0
No Patients Suffered From:
Atrial Esophageal Fistula
Pulmonary Vein Stenosis
Procedural Characteristics
69.0
Mean Procedure Time (min)
47.3
Mean LA Dwell Time (min)
15.8
Mean Fluoroscopy Time (min)
Performance and Biophysical Characteristics
96.2%
Acute PVI
81.4%
Single Shot Success
1.3
Mean Cryoablations per PV
98.1%
Grade 3-4 Occlusion
-56.3
Mean Nadir Temp (°C)
50
Mean Time to Isolation (sec)
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.
CHARISMA – 10-Month Follow- Up Data
prospective , non randomize, 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
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.
Biophysical parameters to predict acute PVI
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.
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
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.
Head-to-Head Data
Click below to access to the full papers
Yap et al. | Multicenter2; Kochi et al. | Single Center3
Creta et al. | Single Center4; Tilz et al. | Single Center5
Mojica et al. | Single center6
CE MARK DATA
Non-randomized, single-arm, prospective, multicenter study to assess safety and effectiveness of POLARxTM 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. Multicenter1
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