Development of pulsed field ablation

Explore the Medtronic development journey of irreversible electroporation (IRE), pulsed field ablation (PFA), and the science behind the novel cardiac ablation technology.

View the PULSED AF pivotal trial results now.

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Caution: Investigational device, limited to investigational use only. Not available for sale in the U.S. The PULSED AF clinical evidence has not been evaluated by the FDA.

PULSED AF clinical trial 

PULSED AF clinical results1 [NCT04198701]

PULSED AF was a global, paired single arm, prospective, non-randomized study that evaluated the safety and effectiveness of the PulseSelect™ pulsed field ablation system for the treatment of patients with paroxysmal (PAF) or persistent (PsAF) atrial fibrillation. The study was conducted in nine countries across 41 sites and 67 operators. The primary analysis included 300 symptomatic AF patients, refractory to class I or III antiarrhythmic drugs, of which 150 were paroxysmal and 150 were persistent. 96% (287) of patients completed 12-month follow-up.

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Primary safety endpoint

Primary safety endpoint

0.7%

Primary adverse events

Performance goal of < 13%
(95% CI, 0.1 to 4.6%)

  • 0 PV stenosis
  • 0 Phrenic nerve injury
  • 0 Esophageal events
  • 1 Tamponade
  • 1 Stroke
  • 0 Major bleeding
  • 0 Myocardial infarction
  • 0 Pericarditis
  • 0 Transient ischemic attack
  • 0 Vagal nerve injury
  • 0 Vascular access complications
  • 0 Systemic pulmonary embolism
  • 0 Pulmonary edema
  • 0 Death
  • 0 Cardiovascular hospitalization

12-month effectiveness data

The primary effectiveness endpoint was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure.

PULSED AF monitoring strategy
  • 3-, 6-, 12-month 12-lead ECG
  • 6-, 12-month 24-hour Holter monitor
  • Weekly trans-telephonic monitoring (TTM) 3–12 months
Primary effectiveness

Acute procedure failure, AF/AFL/AT recurrence, direct cardioversion, repeat ablation, new/reinitiated/increased AADs, any subsequent AF surgery.

Performance goal: > 50% for PAF at 12 months, and > 40% for PsAF at 12 months

  • 66% PAF: (95% CI, 57.9 to 73.2)
  • 55% PsAF: (95% CI, 46.7 to 62.7)
Freedom from AF/AT/AFL
  • 70% PAF
  • 62% PsAF

Quality-of-life scores improved post-ablation compared to baseline

Procedural data (ancillary endpoints)

  

PULSED AF pilot results2

Acute pilot results of the PULSED AF trial were first presented as a late-breaking clinical trial at Heart Rhythm Society (HRS) in May 2020 by Dr. Atul Verma. This was the first in-human evaluation of the novel pulsed field ablation system from Medtronic to measure safety and acute effectiveness in 38 patients with paroxysmal or persistent atrial fibrillation followed for 30 days.

Read more about the PULSED AF pilot trial.

Discover results
Decorative element

Therapy delivery with no phrenic nerve injury, esophageal injury, or stroke

Decorative element

Ostial and antral isolation

Decorative element

Maximum esophageal temperature of 36.14 ± 0.34 °C

Decorative element

100% acute electrical isolation in 152 pulmonary veins

Decorative element

Average electrode temperature rise of 2.1 ± 2.2 ºC at one second post-ablation

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Medtronic development journey of PFA

Medtronic has completed extensive preclinical and clinical work since 2006 to understand the safety and efficacy of IRE for cardiac ablation.

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2006–2019

2020–2023

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The application of irreversible electroporation for pulsed field ablation

Listen to Professor Damijan Miklavčič explain the fundamentals of electroporation and the phenomenon of nonselective transmembrane transport across a cell membrane.

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Medtronic Scientific Exchanges

PART 1: Pulsed field ablation: Fundamentals of electroporation

Watch Damijan Miklavčič, Ph.D., Atul Verma, M.D., and Khaldoun Tarakji, M.D. discuss the fundamentals of electroporation and how it applies to pulsed field ablation.

Log in to Medtronic Academy to view the recording.

Watch the video
Video still of Damijan Miklavčič, Atul Verma, and Khaldoun Tarakji in their discussion of IRE and how it applies to PFA

PART 2: Pulsed field ablation: Fundamentals of tissue selectivity

Watch Damijan Miklavčič, Ph.D., David Haines, M.D., Atul Verma, M.D., and Khaldoun Tarakji, M.D. discuss the fundamental biology of tissue selectivity, preclinical characterization of collateral tissue effects with PFA technology, and the clinical PULSED AF pilot acute safety and pivotal study design.

View the recording
Video still of Damijan Miklavcic, David Haines, Atul Verma, and Khaldoun Tarakji in discussion of tissue selectivity and PFA

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References

1

Verma A, Haines DE, Boersma LV, et al. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023. [Online ahead-of-print].

2

Verma A, Boersma L, Haines DE, et al. First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial. Circ Arrhythm Electrophysiol. January 2022;15(1):e010168.