Development of pulsed field ablation

 

Explore the published data about PulseSelectTM pulsed field ablation system from Medtronic.

Pulse Field Ablation

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 atrial fibrillation (PsAF). 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, 150 patients had paroxysmal AF and 150 patients had persistent AF. 96% (287) of patients completed 12-month follow-up.

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Primary safety endpoint

Primary safety endpoint

0.7%

Primary safety events

FDA guided 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, arrhythmia recurrence, direct cardioversion, repeat ablation, new/reinitiated/increased AADs, any subsequent AF surgery.

FDA guided 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

 

The Medtronic PulseSelect™ pulsed field ablation (PFA) system

is a novel system that is designed to use pulsed electric fields to ablate cardiac tissue through the mechanism of irreversible electroporation.

Pulse Field Ablation

A field-based approach to cardiac ablation

Different from traditional methods of ablation that heat or cool cardiac tissue, the PulseSelect PFA system uses a non-thermal approach and preferentially targets heart tissue with the potential to reduce unwanted collateral damage to surrounding structures in the heart. 

Medtronic PulseSelect™ PFA System

1 - Steerable Multi-electrode Loop Catheter

  • Sense, pace, and ablate from all 9 electrodes
  • Over-the-wire (.032”) , bidirectional
  • 25mm diameter loop

2 - Custom PFA Generator

3 - ECG-Gated

All deliveries automatically synchronized to occur during the ventricular refractory period.

4 - Tableside control

5 - 10Fr bidirectional sheath

Pulse Select parts

The Medtronic PFA Research Journey

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2006

Preclinical testing initiated by Medtronic to evaluate electroporation for cardiac surgery

2008

2009

2014

2015

2018

2019

2020

2021

2022

2023

PULSED AF pilot results2

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

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Average electrode temperature rise of 2.1 ‡ 2.2°C at one second post-ablation

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100% acute electrical isolation in 152 pulmonary veins

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Maximum esophageal temperature of 36.14 ‡ 0.34 °C

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Ostial and antral isolation

Acute pilot results of the PULSED-AF 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.

Medtronic Scientific Exchanges

Pulsed field ablation: Fundamentals of electroporation (Part 1)

A recording of the Scientific Exchange webinar is now available on Medtronic Academy. 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.

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

Pulsed field ablation: Fundamentals of tissue selectivity (Part 2)

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.

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.