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

The University of Texas System (UT)

Status

Withdrawn

Conditions

Atrial Fibrillation

Treatments

Device: Wide area circumferential ablation (WACA)

Device: PVS-PVI targeted ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT06701292

HSC-MS-24-0150

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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