CompletedNot Applicable

Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy

United States141 participantsStarted 2023-09-28

Plain-language summary

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.

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: * Age 18 or older. * Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA). * Previous surgical or catheter ablation for atrial fibrillation is allowed * Planned for a catheter ablation procedure * Able and willing to provide written consent and comply with all testing and follow-up requirements * Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm Exclusion Criteria: * Documented "active" left atrial thrombus * Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.) * Previous PCI/MI within the past 1 month * Active systemic infection or sepsis * Uncontrolled heart failure - New York Heart Association (NYHA) function class IV. * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation. * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment. * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial. * Life expectancy or other disease processes likely to limit survival to less than 1…

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

Number of participants with acute procedural success

Timeframe: up to 12 months post-procedure

Trial details

NCT IDNCT06056557

SponsorVivek Reddy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-18

View on ClinicalTrials.gov More Atrial Fibrillation, Paroxysmal or Persistent trials