OMNYPULSE Catheter + TRUPULSE Generator for Atrial Fibrillation
(Omny-IRE Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Biosense Webster, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a special device that helps correct irregular heartbeats by sending energy to specific areas of the heart. It targets people who have episodes of irregular heartbeats that come and go. The device works by blocking abnormal signals to help the heart beat normally.

Eligibility Criteria

This trial is for individuals with symptomatic paroxysmal atrial fibrillation (PAF) who are selected for a pulmonary vein isolation procedure. Participants must be able to consent and follow the study's requirements. Exclusions include those with certain heart conditions, implanted devices that interfere with the study, severe organ issues, or major health problems that could affect participation.

Inclusion Criteria

I have been diagnosed with a type of irregular heartbeat that stops on its own or with treatment within a week and causes me symptoms.

I am willing and able to give my consent.

Able and willing to comply with all pre-, post- and follow-up testing and requirements

+1 more

Exclusion Criteria

You have a pre-existing neurological problem that has not been resolved.

I do not have any current infections or severe illnesses.

I have not had unstable chest pain in the last 6 months.

+30 more

Participant Groups

The trial tests the safety and effectiveness of an ablation system consisting of the OMNYPULSE Bi-directional catheter and TRUPULSE generator in isolating atrial pulmonary veins to treat PAF.

1Treatment groups

Experimental Treatment

Group I: OMNYPULSE Bi-Directional Catheter with TRUPULSE GeneratorExperimental Treatment1 Intervention

Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).