BENITIONSClinical Trial Intelligence

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

N/A Completed NCT05971693

ConditionAtrial Fibrillation
PhaseN/A
SponsorBiosense Webster, Inc.
StatusCompleted
Enrollment188 participants
InterventionsOMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Start dateSep 12, 2023
Completion dateDec 10, 2024
Results postedMar 25, 2026

Summary

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

Open in BENITIONS View on ClinicalTrials.gov

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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.