Development of pulsed field ablation
Explore the published data about PulseSelectTM pulsed field ablation system from Medtronic.
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.
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
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.
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
The Medtronic PFA Research Journey
PULSED AF pilot results2
Therapy delivery with no phrenic nerve injury, esophageal injury, or stroke
Average electrode temperature rise of 2.1 ‡ 2.2°C at one second post-ablation
100% acute electrical isolation in 152 pulmonary veins
Maximum esophageal temperature of 36.14 ‡ 0.34 °C
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.
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.
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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.