BENITIONSClinical Trial Intelligence

A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator

該当なし 完了 NCT05971693

対象疾患Atrial Fibrillation
該当なし
スポンサーBiosense Webster, Inc.
ステータス完了
参加者数188 名
介入(薬剤)OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
開始日2023年9月12日
完了日2024年12月10日
結果公開日2026年3月25日

概要

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Percentage of Participants With Primary Adverse Events (PAEs)

90 days post catheter insertion on Day 0 · Percentage of participants

Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator0 Percentage of participants
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator0 Percentage of participants
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator0 Percentage of participants
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator0 Percentage of participants
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator0 Percentage of participants
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator0 Percentage of participants

Percentage of Participants With Acute Effectiveness Success

Immediately post-procedure on Day 0 (post catheter insertion) · Percentage of participants

Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator100 Percentage of participants
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator100 Percentage of participants

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