BENITIONSClinical Trial Intelligence

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

Не применимо Завершено NCT05971693

ЗаболеваниеAtrial Fibrillation
ФазаНе применимо
СпонсорBiosense Webster, Inc.
СтатусЗавершено
Участники188 участн.
ВмешательствоOMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Дата начала12.09.2023
Дата завершения10.12.2024
Публикация результатов25.03.2026

Кратко

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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