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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)
Boston Scientific(INDUSTRY)
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