Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) With Omnipolar Mapping Technology
Withdrawn before enrolling · Not applicable
Conditions studied: Atrial Fibrillation
In brief
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).
Key facts
- Study ID
- NCT06701292
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 0
- Starts
- 2025-01-15
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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