BENITIONSClinical Trial Intelligence

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

단계 해당 없음 완료 NCT05971693

대상 질환Atrial Fibrillation
임상 단계단계 해당 없음
스폰서Biosense Webster, Inc.
상태완료
참여자 수188 명
중재(약물)OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
시작일2023년 9월 12일
완료일2024년 12월 10일
결과 공개일2026년 3월 25일

요약

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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