Pulsed field ablation
Sphere-360™ catheter received CE Mark
Features
Exclusively integrated with Affera™ mapping and ablation system
All-in-one:
single-shot PFA catheter with 10 Fr shaft
Tissue-conformable lattice tip
Rotation-free ablation
Adjustable shape:
fully expandable to 34 mm
Study purpose and design
The Sphere-360™ European study was a prospective, single-arm, multicenter trial designed to evaluate safety, effectiveness, and lesion durability of the Sphere-360™ catheter when used for the treatment of symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients (n = 100). Results of this study are outlined in the manuscript ”One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation” linked below.
Learn more about the study.
Trial results1
This study was a prospective, single-arm trial evaluating the safety, efficacy, and durability of the Sphere-360™ PFA catheter for the treatment of PAF.
Efficacy outcomes
Freedom from AF/AT/AFL
AA burden with continuous monitoring for recurrent patients†
Daily AA burden (%)
PV durability‡
PFA lesion durability demonstrated by invasive remapping 75 days post-ablation
Safety outcomes
0
primary adverse events§
Applications per PV
4.0 ± 1.3
applications per PV
Average procedure time◊
58 min
procedure time¶
22 min
LA dwell time
< 12 min
PV transpired time
< 7 min
fluoroscopy time#
PVI: Pulmonary vein isolation; AF: Atrial fibrillation; AT: Atrial tachycardia; AFL: Atrial flutter; AA: Atrial arrhythmia; PV: Pulmonary vein; LA: Left atrial.
† N = 15 patients monitored with ILR in PULSE3 cohort; and AF burden measured for 3 recurrent patients.
‡ Fifty patients treated with the PULSE3 optimized and most recent waveform configuration, 40 of which completed the optional remapping procedure.
§ See manuscript for all adverse event incidence.
◊ See manuscript for full listing of procedural characteristics.
¶ Includes 20-minute wait time.
# Four patients done with 0 fluoroscopy workflow, 26 patients with less than or equal to 3 minutes of fluoroscopy.