Trial results for a study investigating the OMNYPULSE Bi-directional catheter and TRUPULSE generator for Paroxysmal Atrial Fibrillation (PAF) were posted on ClinicalTrials.gov on 2026-03-25, reporting primary adverse events at 2.5% in the Roll-In Analysis Set and 2.2% in the Main Safety Analysis Set.
Background
Atrial fibrillation (AFib) is a common heart rhythm disorder characterized by irregular and often rapid heartbeats, which can lead to symptoms like palpitations, fatigue, and shortness of breath. Paroxysmal atrial fibrillation (PAF) refers to episodes that start and stop on their own, typically lasting less than seven days. Untreated AFib can increase the risk of stroke and other heart-related complications. Current treatment strategies often include medications to control heart rate and rhythm, as well as catheter ablation procedures aimed at isolating the pulmonary veins, which are frequently the source of abnormal electrical signals triggering AFib. The development of new ablation systems, such as the OMNYPULSE catheter and TRUPULSE generator, seeks to improve the safety and effectiveness of these procedures for patients with PAF.
Trial design
This completed study, identified as Phase NA, enrolled 188 participants with Atrial Fibrillation. The trial's primary purpose was to demonstrate the safety and effectiveness of the OMNYPULSE Bi-directional catheter and TRUPULSE generator ablation system when used for isolation of the atrial pulmonary veins (PVs) in the treatment of participants with paroxysmal atrial fibrillation (PAF). The intervention involved the use of the OMNYPULSE Bi-directional catheter and TRUPULSE generator system.
Key results
The trial results focused on the safety profile of the OMNYPULSE Bi-directional catheter and TRUPULSE generator system, specifically reporting the percentage of participants experiencing Primary Adverse Events (PAEs):
- In the Roll-In Analysis Set for the OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator, the percentage of participants with Primary Adverse Events (PAEs) was 2.5%.
- In the Main Safety Analysis Set for the OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator, the percentage of participants with Primary Adverse Events (PAEs) was 2.2%.
Other reported instances of Primary Adverse Events (PAEs) in both the Roll-In and Main Safety Analysis Sets were 0%, indicating a low incidence of specific adverse events.
What this means
The posted trial results indicate a favorable safety profile for the OMNYPULSE Bi-directional catheter and TRUPULSE generator ablation system in patients with paroxysmal atrial fibrillation. With Primary Adverse Events (PAEs) reported at 2.5% in the Roll-In Analysis Set and 2.2% in the Main Safety Analysis Set, the data suggests that the system is associated with a low rate of complications. These findings are important for clinicians considering new ablation technologies for pulmonary vein isolation in PAF patients, as a strong safety profile is a critical factor in treatment decisions. The low incidence of adverse events could potentially enhance patient confidence and expand the applicability of catheter ablation for AFib management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05971693, titled "A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator", were posted on 2026-03-25 on clinicaltrials.gov.