A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
N/A
Completed
NCT05971693
| Condition | Atrial Fibrillation |
|---|
| Phase | N/A |
|---|
| Sponsor | Biosense Webster, Inc. |
|---|
| Status | Completed |
|---|
| Enrollment | 188 participants |
|---|
| Interventions | OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator |
|---|
| Start date | Sep 12, 2023 |
|---|
| Completion date | Dec 10, 2024 |
|---|
| Results posted | Mar 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 Generator | 0 Percentage of participants |
|---|
| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
|---|
| Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
|---|
| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
|---|
| Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
|---|
| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 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 Generator | 100 Percentage of participants |
|---|
| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 100 Percentage of participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
Other trials for this condition
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.