Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.
Interventions
DEVICEVytronUS Ablation System
Pulmonary vein isolation.
Sponsors
VytronUS, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years old. * Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.
Exclusion criteria
* Prior pulmonary vein isolation * Presence of intracardiac thrombus * Indication of inaccessible pulmonary or cardiac anatomy * Myocardial infarction, PCI, or cardiac surgery in prior three months * Moderate to severe valvular disease or prior valve replacement * NYHA Class IV * LVEF \< 40% * Previous stroke or TIA * Serum creatinine \> 2.5mg/dL or allergy to intravenous contrast agents * Existing bleeding diathesis or history of complications with anticoagulation therapy * Women who are nursing, pregnant, or trying to become pregnant * Subjects unwilling or unable to provide consent * Participation in a drug or device trial that would prevent completion of required study procedures * Active implantable devices * Major organ system disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device or procedure related adverse events. | Three months post procedure. |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary vein isolation. | Three months post procedure. |
Countries
Czechia
Outcome results
None listed