The purpose of this study is to assess the performance and safety of using the investigational catheter.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
* Signed participants Informed Consent Form (ICF)
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
* Structural heart defect which can only be repaired by cardiac surgery
* Pericarditis within 6 months
* Left ventricular ejection fraction (LVEF) less than or equal to (\<=) 25 percent (%) for ventricular tachycardia (VT) participants
* LVEF \<= 40% for participants with atrial arrhythmia
* History of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux
* History of abnormal bleeding and/or clotting disorder
* Clinically significant infection or sepsis
* History of stroke or transient ischemic attack (TIA) within the past 6 months of enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
* Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
* Implanted with a mechanical valve
* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Any of the following within 6 months of enrol…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
Timeframe: At Day 1
2
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Timeframe: From day of index procedure (Day 1) up to 7 days