Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF

Study Overview
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Brief Summary
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The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective, single-center, non-randomized investigation.

Detailed Description
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The design for this study involves the sequential enrollment of patients with documented paroxysmal atrial fibrillation who have had two (2) or more AF episodes for at least 30 seconds in length within six (6) months prior to enrollment. Target population shall be selected from the treatable AF population that meets both inclusion/exclusion criteria.It is intended that the Vado Steerable Sheath will be used as part of standard clinical workflow procedures, with no procedural deviations relative to other procedures requiring steerable sheaths. Individual subjects will be studied during mapping and ablation procedures and followed until release from hospital post procedure per institutional standard of care.

Official Title
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Vado™ Steerable Sheath System; A Safety and Performance Study to Evaluate Access to the Pulmonary Veins in the Treatment of Paroxysmal and Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Steerable Sheath System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS Criteria. Eighteen to Eighty years of age Signed informed consent Exclusion Criteria: Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement Severe cerebrovascular disease or history of cerebrovascular event within one (1) month Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29. Active gastrointestinal bleeding, infection or fever (> 100.5/38C) Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease Structural heart disease of clinical significance including Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing Stable/unstable angina or ongoing myocardial ischemia Myocardial infarction (MI) within three months of enrollment Aortic or mitral valve disease > Grade II Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study Active infection or sepsis Female patient is pregnant or lactating Untreatable allergy to contrast media Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes History of blood clotting (bleeding or thrombotic) abnormalities Known sensitivities to heparin or warfarin Severe COPD (identified by an FEV1 <1)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steerable sheath for intracardiac access<br>Vado Steerable sheath system consisting of a dilator and steerable sheath for left atrial access, positioning of ablation catheters and placement of mapping and ablation catheters for circumferential ablation | Device: Steerable Sheath System<br>* The Vado™ Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible catheter positioning in the cardiac anatomy.<br>* Other names: Vado Steerable Sheath;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of adverse device related events at release from hospital post procedure per institutional standard of care | Steerability and positioning to facilitate catheter placement | Procedure through 7 day clinical follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis and Visibility of the steerable sheath | Safe event free insertion of the steerable sheath system in the femoral vein | Procedure through 7 day clinical follow up |