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 range18 Years

SexALL

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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

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)

Number of radiofrequency applications used

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