What is the mechanism of action of this treatment?

The most common treatments for Atrial Fibrillation (AF) include catheter ablation, electrical cardioversion, and pharmacologic therapy. Catheter ablation, such as the OMNYPULSE Bi-directional catheter and TRUPULSE generator, works by creating scars in the heart tissue to isolate the pulmonary veins and disrupt faulty electrical signals, thereby preventing the erratic heartbeats characteristic of AF. Electrical cardioversion involves delivering a controlled electric shock to the heart to restore normal rhythm, while pharmacologic therapy uses medications to either control the heart rate or maintain sinus rhythm. These treatments are crucial for AF patients as they help manage symptoms, reduce the risk of stroke, and improve overall heart function and quality of life.

What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include antiarrhythmic drugs, electrical cardioversion, and catheter ablation. Antiarrhythmic drugs can cause side effects such as dizziness, fatigue, and proarrhythmia (new or worsening arrhythmias). Electrical cardioversion may lead to skin burns and transient arrhythmias. Catheter ablation, similar to the OMNYPULSE and TRUPULSE system, involves creating scars in heart tissue to isolate pulmonary veins and disrupt faulty electrical signals. Known side effects of catheter ablation include bleeding, infection, damage to blood vessels, and in rare cases, stroke or heart perforation. Patients may also experience post-procedural pain and transient arrhythmias.

What prior FDA approvals exist?

The FDA has approved several catheter ablation systems for the treatment of Atrial Fibrillation (AF), which work by creating scars in the heart tissue to isolate the pulmonary veins and disrupt faulty electrical signals. Notable examples include the ThermoCool SmartTouch Catheter, which uses radiofrequency energy, and the Arctic Front Advance Cardiac CryoAblation Catheter, which uses cryoablation to achieve similar results. These treatments are designed to target and isolate the areas of the heart responsible for initiating and maintaining AF, thereby restoring normal heart rhythm.

What other types of research exist?

Promising novel alternatives to the OMNYPULSE Bi-directional catheter and TRUPULSE generator for atrial fibrillation treatment include: 1) Cryoballoon ablation, which uses extreme cold to create lesions and isolate pulmonary veins. 2) Steerable sheath technology, which enhances catheter positioning and stability, potentially improving the success rate of ablation procedures. 3) Nd:YAG laser ablation, which creates linear lesions in the myocardium using diffusing optical fibers. These alternatives offer different mechanisms to achieve the same goal of disrupting faulty electrical signals in the heart.

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Procedure

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

N/A

Waitlist Available

Research Sponsored by Biosense Webster, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Selected for AF ablation procedure by pulmonary vein isolation (PVI)

Be older than 18 years old

Must not have

Acute illness, active systemic infection, or sepsis

Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate post-procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the catheter insertion site, bleeding or bruising, heart rhythm disturbances during or after treatment, and risks associated with sedation used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am chosen for a procedure to treat irregular heartbeat using PVI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any current infections or severe illnesses.

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I have had heart surgery, including bypass or valve procedures.

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I have a blood clot in my heart's left atrium.

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I have a history of blood clotting or bleeding issues, or I cannot take blood thinners.

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I have a serious lung condition that causes chronic symptoms.

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I have had a clot or a mini-stroke in the last 6 months.

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I have been diagnosed with persistent AFib lasting more than 7 days.

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My heart's left atrium is severely enlarged.

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My heart's pumping ability is significantly reduced.

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I do not have severe or uncontrolled heart failure.

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I have a heart condition that prevents safe catheter use.

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I have been diagnosed with narrowed blood vessels in my lungs.

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I have severe leakage in my heart's mitral valve.

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I have severe heartburn that isn't controlled by medication.

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I have had a previous procedure on the left side of my heart.

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I need a procedure for heart rhythm problems not related to the pulmonary veins.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within day 91 to day 365 post-ablation procedure (on day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within day 91 to day 365 post-ablation procedure (on day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within day 91 to day 365 post-ablation procedure (on day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Primary Adverse Events (PAE's)

Percentage of Participants with Acute Effectiveness

Secondary study objectives

12-month Effectiveness: Number of Participants who Achieved Freedom from Documented Atrial Arrhythmia Episodes During the Effectiveness Evaluation period (AF, AT or AFL of Unknown Origin) within Day 91 to Day 365 Post Index Procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atrial Fibrillation (AF) include catheter ablation, electrical cardioversion, and pharmacologic therapy. Catheter ablation, such as the OMNYPULSE Bi-directional catheter and TRUPULSE generator, works by creating scars in the heart tissue to isolate the pulmonary veins and disrupt faulty electrical signals, thereby preventing the erratic heartbeats characteristic of AF. Electrical cardioversion involves delivering a controlled electric shock to the heart to restore normal rhythm, while pharmacologic therapy uses medications to either control the heart rate or maintain sinus rhythm. These treatments are crucial for AF patients as they help manage symptoms, reduce the risk of stroke, and improve overall heart function and quality of life.

How to manage atrial fibrillation: an update on recent clinical trials.