WithdrawnNot Applicable

Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology

Stopped: lack of recruitment after technological advances replaced the study procedure.

United States0Started 2025-01-15

Plain-language summary

The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).

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: * Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications * A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder * Capability to provide informed consent Exclusion Criteria: * Persistent or permanent AF * Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter * Reversible causes of AF * Congenital heart disease * Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation) * Pregnancy * Known presence of intracardiac thrombus * Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia * Broad vortex-like connections and no clear PVMS to be targeted

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 minutes taken from Initial puncture to transseptal access

Timeframe: From time of Initial puncture to time of transseptal access (an average of 10 minutes)

Number of minutes taken from transseptal access to left atrium 3D map completion

Timeframe: From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)

Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated

Timeframe: From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)

Number of minutes with catheters in the left atrium

Timeframe: from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)

Time from initial puncture till all sheaths removed

Timeframe: From time of initial puncture to time when all sheaths removed (an average of 90 minutes)

Total time of radiofrequency applications in seconds

Timeframe: from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)

Trial details

NCT IDNCT06701292

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Atrial Fibrillation trials