None listed
Conditions
Brief summary
Participants in this study will have an abnormal heart rhythm called paroxysmal atrial fibrillation. They will be scheduled for an ablation to try to control this rhythm. All participants will have this scheduled as part of their clinical management as discussed with their cardiologist. To perform this procedure the cardiologist needs to put a small catheter into the left upper chamber of the heart. The catheter is inserted into a vein in the leg and threaded into the top right chamber of the heart. From there a small puncture (transseptal puncture) is made through the wall that separates the atria (top chambers) to allow access to the left side. The AccessPath™ Transseptal Introducer Sheath System is designed to improve the precision and safety of transseptal access in preparation for the ablation procedure by helping the doctor to more accurately position the needle to make the puncture in the correct position. This trial assesses the design and function of the AccessPath™ Transseptal Introducer Sheath System, which consists of an introducer, guidewire and dilator with suction flute. Fluoroscopy (x-rays) will be used to visually confirm positioning of the AccessPath™ Transseptal Introducer Sheath throughout the procedure. It is usual for x-rays to be used for this procedure. The doctor will use the AccessPath™ Transseptal Introducer Sheath System in accordance with the Instructions for Use (IFU) and follow his/her standard practice for performing an ablation procedure for atrial fibrillation. It is expected that the AccessPath™ Transseptal Introducer Sheath System will be used as part of the procedure, with no changes required. The doctor will then perform the necessary ablation procedure. The participant will stay in hospital overnight and have the standard tests performed, ECG and echocardiogram (ultrasound of the heart)to rule out any complications before being discharged. Study participation will end on discharge from hospital.
Interventions
an electrophysiologist will insert the transseptal introducer sheath and dilator assembly into the vein over a standard guidewire and advanced until the sheath tip is in the SVC. A transseptal needle is flushed as in normal standard of care and inserted into the sheath assembly once an appropriate angle is set under fluoroscopy with the access path. The access path assists by setting the angle to cross the septum. The transseptal needle is then pushed across the interatrial septum under fluorosc
an electrophysiologist will insert the transseptal introducer sheath and dilator assembly into the vein over a standard guidewire and advanced until the sheath tip is in the SVC. A transseptal needle is flushed as in normal standard of care and inserted into the sheath assembly once an appropriate angle is set under fluoroscopy with the access path. The access path assists by setting the angle to cross the septum. The transseptal needle is then pushed across the interatrial septum under fluoroscopy. This use is no different from normal standard of care for transseptal access.
Sponsors
CardioPathways, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
suitable candidate scheduled for percutaneous transseptal access for atrial fibrillation ablation procedures Eighteen to eighty years of age 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 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
Outcome results
None listed