Vado 'trademark' Steerable Sheath System; A Safety and Performance Study to evaluate access to the Pulmonary Veins in the Treatment of Paroxysmal and Persistent Atrial Fibrillatio

Not Applicable

Completed

• Conditions: paroxysmal atrial fibrillation; atrial fibrillation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000406606
• Lead Sponsor: Kalila Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified