パルスフィールドアブレーションによる組織への不可逆的な電気穿孔と心房細動の治療

基本情報

NCT ID

NCT04198701

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

421

治験依頼者名

Medtronic Cardiac Ablation Solutions

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (4)