BENITIONSClinical Trial Intelligence

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

不适用 已完成 NCT05971693

适应症Atrial Fibrillation
分期不适用
申办方Biosense Webster, Inc.
状态已完成
受试者人数188 人
干预(药物)OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
开始日期2023年9月12日
完成日期2024年12月10日
结果公布日2026年3月25日

摘要

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

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。