OMNYPULSE Catheter + TRUPULSE Generator for Atrial Fibrillation

(Omny-IRE Trial)

Recruiting at 16 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Thyroid disease, Renal insufficiency, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

149 Participants Needed

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the OMNYPULSE Catheter + TRUPULSE Generator treatment for atrial fibrillation?

Low energy transvenous atrial defibrillation using catheters has been shown to be effective in converting atrial fibrillation to a normal heart rhythm, as demonstrated by the successful use of an implantable atrial defibrillator in a patient with symptomatic atrial fibrillation. ^{1 2 3 4 5}

How is the OMNYPULSE Catheter + TRUPULSE Generator treatment for atrial fibrillation different from other treatments?

The OMNYPULSE Catheter + TRUPULSE Generator treatment is unique because it uses a catheter-based approach to deliver low-energy electrical pulses directly to the heart, aiming to restore normal rhythm in patients with atrial fibrillation. This method is different from traditional drug therapies and offers a non-drug option that may be combined with other treatments for better results. ^{2 6 7 8 9}

Research Team

Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial

Principal Investigator

Biosense Webster, Inc., a division of Johnson & Johnson

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablation Procedure

Participants undergo the ablation procedure with the OMNYPULSE catheter and TRUPULSE generator for pulmonary vein isolation

Immediate

1 visit (in-person)

Post-procedure Monitoring

Participants are monitored for primary adverse events within 7 days following the ablation procedure

1 week

Effectiveness Evaluation

Participants are evaluated for freedom from atrial arrhythmia episodes from Day 91 to Day 365 post-procedure

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OMNYPULSE Catheter and TRUPULSE Generator

Trial Overview 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.

Participant Groups

Group I: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Biosense Webster, Inc.

Lead Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

References

1. Finland pubmed.ncbi.nlm.nih.gov

[Update on current care guidelines: atrial fibrillation]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Implantable atrial defibrillator for atrial fibrillation. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

Dronedarone: a review of characteristics and clinical data. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Benefit-risk assessment of current antiarrhythmic drug therapy of atrial fibrillation. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dronedarone for the treatment of atrial fibrillation and atrial flutter: approval and efficacy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Discrimination of sinus rhythm, atrial flutter, and atrial fibrillation using bipolar endocardial signals. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Low-energy transvenous cardioversion of atrial fibrillation using a single atrial lead system. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of continuous and triggered atrial overdrive pacing on paroxysmal atrial fibrillation in pacemaker patients. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Current clinical perspectives on implantable devices for atrial defibrillation. [2019]