Pulsed field ablation
CAUTION: Investigational device, limited to investigational use only. Not available for sale in any geography.
This evidence has not been evaluated by the FDA or for 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.