持続性心房細動におけるCFAE/時空間分散誘導アブレーションとPVI誘導アブレーションの比較

基本情報

NCT ID: NCT02696265
ステータス: 不明
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 180
治験依頼者名: Diagram B.V.

概要

Objective: The purpose of this study is to compare the efficacy and safety of ablation of Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based ablation in patients with persistent AF. Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival compared to a PVI guided ablation. Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into one of two study arms: * CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation. * PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals

対象疾患

Chronic Atrial Fibrillation

介入

CFAE guided ablation(PROCEDURE)

PVI guided ablation(PROCEDURE)

依頼者（Sponsor）

Diagram(OTHER)

ヤンセンファーマ株式会社(INDUSTRY)

Biosense Webster(INDUSTRY)

実施施設 (1)

Kagoshima University

Kagoshima, Japan(RECRUITING)