None listed
Conditions
Brief summary
To confirm the safe insertion of a steerable sheath in the venous system to direct and perform positioning, and removal of the ablation catheter. Ablation is performed when patients have arrhythmias which cause shortness of breath and can be if not treated life threatening. Acute safety evaluation at end of procedure as evidenced by absence of device related adverse events. Our sheath will be used in usual manner as current available steerable sheaths.
Interventions
The Vado is a steerable sheath that will be inserted into the femoral vein and be advanced into the right atrium to the septum. The sheath will be positioned so that an ablation catheter can be inserted and advanced across the septum to ablate the pulmonary veins. Catheter and sheath will be removed after ablation. The procedure is approximately one hour and patient will go home next day. Follow up at discharge only.
Sponsors
Kalila Medical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1.Suitable candidate for intra-cardiac mapping for arrhythmias with documented PAF defined by HRS criteria. 2. Eighteen (18) to eighty (80) years of age 3. Signed Informed Consent
Exclusion criteria
1. Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement 2. Severe cerebrovascular disease or history of cerebrovascular event within one (1) month 3. Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29. 4. Active gastrointestinal bleeding, infection or fever (> 100.5/38C) 5. Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease 6. Structural heart disease of clinical significance including a. 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 b.Stable/unstable angina or ongoing myocardial ischemia c.Myocardial infarction (MI) within three months of enrollment d.Aortic or mitral valve disease > Grade II e. 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 7. Enrollment in any other ongoing arrhythmia study protocol 8. Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study 9. Active infection or sepsis 10. Female patient is pregnant or lactating 11. Untreatable allergy to contrast media 12. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes 13. History of blood clotting (bleeding or thrombotic) abnormalities 14. Known sensitivities to heparin or warfarin 15. Severe COPD (identified by an FEV1 <1)
Outcome results
None listed