Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)

protocol page 30 :

Catheter ablation is established as an acceptable line of treatment for
patients with recurrent
symptomatic atrial fibrillation (both paroxysmal and persistent) who have
failed anti-arrhythmic
drug therapy

Catheter ablation treatment strategies for AF have evolved over time and
currently include
pulmonary vein isolation (PVI) as the cornerstone of ablation therapy in all
types of AF (paroxysmal
and persistent) with several recent studies reporting benefit using a minimal
PVI-only type
strategy

The Medtronic Pulsed Field Ablation (PFA) system is a novel method of PVI
ablation that has the
potential to offer a safer and more effective treatment option for AF over
existing, approved
methods of AF ablation. Medtronic proposes there is a need to investigate PVI
ablation with a novel
technology (i.e., PFA system) that is capable of potentially reducing or
eliminating collateral
damage, improving lesion formation and durability, and reducing the AF ablation
procedure time.

Protocol page 33:

The purpose of the study is to provide data demonstrating the safety and
effectiveness of the PFA
system for the treatment of atrial fibrillation. The study will also provide
first in human insights into
clinical safety and device function of the PFA system for pulmonary vein
isolation as a treatment for
AF.

Pilot Phase Safety Objective:
Assess the incidence of PFA system-related and PFA procedure-related serious
adverse events
(SAEs) within 30 days post-ablation.

Pilot Phase Effectiveness Objective:
Assess the acute procedural success of PVI ablation with the PFA system.

Pivotal Phase Primary Safety Objective:
Demonstrate an acceptable safety profile of PVI ablation with the PFA system.

Pivotal Phase Primary Effectiveness Objective:
Demonstrate an acceptable chronic effectiveness of PVI ablation with the PFA
system, based on
freedom from treatment failure.

protocol page 36:

The study is a prospective, multi-center, non-randomized, unblinded worldwide
pre-market clinical
study. Adult subjects with a history of drug refractory recurrent symptomatic
atrial fibrillation (AF)
will undergo ablation of pulmonary veins and confirmation of entrance block
and, where assessable,
exit block with the PFA system. Following the index ablation procedure and
hospital discharge, all
study subjects from all participating geographies will be followed at 30 days,
3 months, 6 months,
and 12 months, and will be exited from the study at the conclusion of the
12-month follow-up visit
and associated 24-hour Holter

The study consists of a Pilot Phase and a Pivotal Phase. Overall, up to 475
subjects will be enrolled
to ensure there are 20 Pilot Phase subjects, up to 80 Pivotal Phase roll-in
cohort subjects, and 315
Pivotal Phase primary analysis cohort subjects treated with the PFA system, and
to account for
subjects not treated prior to exit.

Protocol page 40:

The Medtronic Pulsed Field Ablation (PFA) system applies bipolar, biphasic
pulsed electric fields
through a circular multi-electrode array catheter to perform cardiac tissue
ablation through
irreversible electroporation. The system is intended to be used for the
treatment of atrial
fibrillation in humans by isolation of the major cardiac veins.

Protocol page 37:

The potential benefits related to the use of the PFA system have been
determined to outweigh any
potential risks, providing justification to proceed with clinical
investigation. Clinical data are needed
to demonstrate that the safety profile and proper lesion creation established
in preclinical testing
is confirmed in a clinical setting. Also, as demonstrated in preclinical
studies the PFA system
offers potential advantages over existing approved or cleared alternatives such
as
reducing/eliminating collateral damage, improving lesion formation and
durability, and reducing
the AF ablation procedure time.