CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 421 enrolled
Drug / intervention
Medtronic PulseSelect Pulsed Field Ablation (PFA) Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04198701
NCT04198701N/ACompleted
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Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

Medtronic Cardiac Ablation Solutions·interventional·Posted Dec 13, 2019·Updated Feb 13, 2025

In Brief

A clinical study evaluating Medtronic PulseSelect Pulsed Field Ablation (PFA) System for Atrial Fibrillation. Completed, enrolled 421 participants across 41 sites in 9 countries.

Detailed Summary

The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesAustralia, Austria, Belgium, Canada, France, Japan, Netherlands, Spain, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 13, 2019
Enrollment StartDec 10, 2019
Primary CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.6 years ago

Interventions

Medtronic PulseSelect Pulsed Field Ablation (PFA) Systemdevice

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 PulseSelect PFA System.