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発作性心房細動の治療における高解像度マッピングを備えたオープン灌流アブレーションカテーテルの前向き評価

基本情報

NCT ID
NCT03729830
ステータス
完了
試験のフェーズ
-
試験タイプ
観察
目標被験者数
415
治験依頼者名
Boston Scientific Corporation

概要

To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).

対象疾患

Paroxysmal Atrial Fibrillation

介入

Boston Scientific Open Irrigated Ablation Catheters(DEVICE)

依頼者(Sponsor)

実施施設 (2)

小倉記念病院

Fukuoka-ken, Japan

国家公務員共済組合連合会横須賀共済病院

Kanagawa Prefecture, Japan