Safety and Performance of the AccessPath™ Transseptal Introducer Sheath in Percutaneous Intracardiac Access via Transseptal Puncture for patients with Atrial Fibrillation Undergoing Catheter Ablation

CardioPathways, Inc.0 个研究点目标入组 10 人开始时间: 2019年3月11日最近更新: 2020年2月24日

适应症

试验速览

暂无简介。

•suitable candidate scheduled for percutaneous transseptal access for atrial fibrillation ablation procedures
•Eighteen to eighty years of age
•Signed informed consent

•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
•creatinine of > 150 ml/min.
•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. Stable/unstable angina or ongoing myocardial ischemia
•b. Myocardial infarction (MI) within three months of enrollment
•c. Aortic or mitral valve disease > Grade II
•d. 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. Female patient is pregnant or lactating
•8. Untreatable allergy to contrast media
•9. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
•10. History of blood clotting (bleeding or thrombotic) abnormalities
•11. Known sensitivities to heparin or warfarin

发起方

CardioPathways, Inc.