PULSED AF was a global, paired single-arm, prospective, nonrandomized study that evaluated the safety and effectiveness of the PulseSelect™ pulsed field ablation (PFA) system for the treatment of patients with paroxysmal (PAF) or persistent (PsAF) atrial fibrillation.
Austria, Belgium, France, Spain, Netherlands, United States, Canada, Australia, Japan.
300 patients
150 paroxysmal (PAF)
150 persistent (PsAF)
The study population included recurrent symptomatic paroxysmal and persistent atrial fibrillation patients refractory to Class I or III antiarrhythmic drugs (AADs).
96% (287)
96% (287) of patients completed 12-month follow-up.
0.7%
Safety event rate
0 esophageal events
0 PV stenosis
0 phrenic nerve injury
0 coronary artery spasm
1/300 cerebrovascular accident
1/300 tamponade
0/300 transient ischemic attack
0/300 major bleeding
0/300 myocardial infarction
0/300 pericarditis
0/300 vagal nerve injury
0/300 systemic pulmonary embolism
0/300 pulmonary edema
0/300 vascular access complications
0/300 cardiovascular hospitalization
0/300 death
Paroxysmal
Persistent
Paroxysmal
65 ± 29 minutes
45-minute procedure
20-minute wait
Left atrial dwell time
Persistent
70 ± 31 minutes
50-minute procedure
20-minute wait
Seconds PAF
25 ± 8
Seconds PsAF
29 ± 10
| Parameter | Paroxysmal (n = 150) | Persistent (n = 150) |
| Skin-to-skin procedural time (min)† | 134 ± 50 | 145 ± 60 |
| Device left atrial dwell time (min)‡ | 65 ± 29 | 70 ± 31 |
| Fluoroscopy time during procedure (min) | 26 ± 17§ | 29 ± 21 |
| Number of applications per procedure | 48 ± 15 | 57 ± 20 |
PULSED AF patients were sedated with general anesthesia, deep sedation, or conscious sedation, and paralytics were not required.
The PulseSelect™ PFA system was used in conjunction with multiple commercially available mapping systems.
Freedom from a composite endpoint of acute procedure failure, AF/AFL/AT recurrence, direct cardioversion, repeat ablation, new/reinitiated/increased AADs, any subsequent AF surgery.
Freedom from a composite of serious procedure- and device-related adverse events. Serious adverse events were prespecified, and their relatedness to the pulsed field ablation system or procedure was adjudicated by the clinical events committee.
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† Operators targeted pulmonary vein isolation using a wide antral approach during PULSED AF procedures.
‡ 87% of operators performed less than 10 cases during trial.
§ Data were available for 149 patients.
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