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Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology | Clinical Trials | Clareo Health

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

Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves With Omnipolar Mapping Technology - A Randomized Pilot Trial

NCT06701292•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

January 15, 2025

Primary Completion Date

April 30, 2025

Completion Date

October 31, 2025

Last Updated

January 28, 2026

Conditions

Atrial Fibrillation

Interventions

PVS-PVI targeted ablation

DEVICE

Wide area circumferential ablation (WACA)

DEVICE

The CONFORM Pivotal Trial

NCT05147792

Atrial FibrillationStroke

View study

RECRUITINGNA

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

NCT06935591

Atrial Fibrillation (AF)

View study

RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

Medtronic Terminate AF Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia