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OMNYPULSE Catheter + TRUPULSE Generator for Atrial Fibrillation (Omny-IRE Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate post-procedure
Awards & highlights
Omny-IRE Trial Summary
This trial tests the safety and effectiveness of a device used to treat atrial fibrillation (PAF) by isolating the pulmonary veins.
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.Check my eligibility
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.See study design
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.
Omny-IRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am chosen for a procedure to treat irregular heartbeat using PVI.
Omny-IRE Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Primary Adverse Events (PAE's)
Percentage of Participants with Acute Effectiveness
Secondary outcome measures
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
Omny-IRE 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).
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Who is running the clinical trial?
Biosense Webster, Inc.Lead Sponsor
122 Previous Clinical Trials
36,427 Total Patients Enrolled
81 Trials studying Atrial Fibrillation
28,344 Patients Enrolled for Atrial Fibrillation
Biosense Webster, Inc., a division of Johnson & Johnson Clinical TrialStudy DirectorBiosense Webster, Inc., a division of Johnson & Johnson
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pre-existing neurological problem that has not been resolved.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 do not have any current infections or severe illnesses.I have not had unstable chest pain in the last 6 months.I have had heart surgery, including bypass or valve procedures.I have a blood clot in my heart's left atrium.I am willing and able to give my consent.I have a history of blood clotting or bleeding issues, or I cannot take blood thinners.You already have paralysis in one side of your diaphragm.I have a serious lung condition that causes chronic symptoms.I have had a clot or a mini-stroke in the last 6 months.I have been diagnosed with persistent AFib lasting more than 7 days.My heart's left atrium is severely enlarged.My heart's pumping ability is significantly reduced.I do not have severe or uncontrolled heart failure.I had a heart procedure or heart attack in the last 2 months.I cannot undergo an MRI due to certain health issues like kidney disease or claustrophobia.I have a heart condition that prevents safe catheter use.You have a major issue with your pulmonary veins that the doctor thinks would make it unsafe for you to join the study.I have been diagnosed with narrowed blood vessels in my lungs.You have a pacemaker or other implanted heart device that could be affected by the treatment's electrical energy.You have a condition that makes it difficult to access your blood vessels.I have severe leakage in my heart's mitral valve.I have severe heartburn that isn't controlled by medication.I have had a previous procedure on the left side of my heart.I have atrial fibrillation due to conditions like thyroid issues or sleep apnea.You have metal pieces in your body that contain iron.You are expected to live for less than 12 months.I expect to have a major surgery, like heart surgery, within a year.I need a procedure for heart rhythm problems not related to the pulmonary veins.I am chosen for a procedure to treat irregular heartbeat using PVI.I am not pregnant, breastfeeding, or planning to become pregnant during the study.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widespread is the implementation of this research investigation?
"Currently, the research is available in 13 different locations including Brugge, Genk and Hasselt. It would be most convenient to choose a site closest your home in order to reduce commuting stress if you become part of this study."
Answered by AI
To what demographic does this research study apply?
"Eligible contenders must have atrial fibrillation and be within the 18-75 age range. In total, this clinical trial needs 185 participants to complete its objectives."
Answered by AI
Do the qualifications for this experiment encompass those aged 40 or older?
"Potential recruits aged 18 to 75 are eligible for this trial. Meanwhile, 11 trials focus on children while 487 cater exclusively to senior citizens."
Answered by AI
Are there still slots available for participants in this clinical trial?
"As per the information found on clinicaltrials.gov, this particular study is not recruiting participants at present time, having been initially published on July 28th 2023 and last edited two days ago. That said, there are 490 other trials in need of patients to join right now."
Answered by AI
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