Cardiac ablation and mapping


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.

Global multicenter study

9 countries

Austria, Belgium, France, Spain, Netherlands, United States, Canada, Australia, Japan.

41 sites

67 operators

Global map with some countries represented in light blue dots and other represented in navy blue dots



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) of patients completed 12-month follow-up.

Study purpose and design

Expand All

Unmatched safety

Unmatched safety1,2

  • One of the lowest safety event rates of any IDE trial for AF ablation to date
  • No esophageal events, phrenic nerve injury, PV stenosis, or coronary spasm observed
  • Performance goal of < 13%


safety event rate

0 esophageal events

0 PV

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

Proven efficacy

Rigorous arrhythmia monitoring

Engineered efficiency

Watch the scientific exchange.

Pulsed field ablation: Fundamentals of PULSED AF

Watch John Hummel, M.D., Atul Verma, M.D., and Khaldoun Tarakji, M.D. review the PULSED AF procedural workflow and the long-term results of the PULSED AF pivotal trial.

Endpoint definitions

Primary efficacy endpoint

Freedom from a composite end point of acute procedure failure, AF/AFL/AT recurrence, direct cardioversion, repeat ablation, new/reinitiated/increased AADs, any subsequent AF surgery.

Primary safety endpoint

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.

Study population

Key inclusion criteria

  • Age 18–80
  • Diagnosis of recurrent symptomatic PAF or PsAF
  • Drug refractory to Class I or III AADs

Key exclusion criteria

  • Left atrial diameter > 5.0 cm 
  • Prior left atrial ablation or surgery
  • Left ventricular ejection fraction < 35%
  • Implantable cardiac devices
  • Heart surgery within three months or stroke within six months of enrollment

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.



Verma A, Haines DE, Boersma LV, et al. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. May 9, 2023;147(19):1422–1432.


Medtronic data on file. November 2023.