None listed
Conditions
Brief summary
The device studied in this trial is an intracardiac echocardiographic catheter intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology in the heart of adult and pediatric patients. It is for imaging guidance only. The study is intended to evaluate images acquired by the catheter during percutaneous procedures in which access to the left atrium is performed via transseptal puncture. Safety criteria based on ability to image adequately as evidenced by the absence of device or procedure related adverse events.
Interventions
the imaging probe for echocardiographic imaging will be will be performed using a catheter probe with the ability to use echo to image cardiac structure like the right atrium to visualize the intra atrial septum where a catheter for ablation will be passed through a sheath to deliver therapy. This is performed by an electrophysiologist. The setting is in a catheterization lab. Imaging will occur only once in the first part of the procedure prior to therapy and typically is in the range of 10 min
the imaging probe for echocardiographic imaging will be will be performed using a catheter probe with the ability to use echo to image cardiac structure like the right atrium to visualize the intra atrial septum where a catheter for ablation will be passed through a sheath to deliver therapy. This is performed by an electrophysiologist. The setting is in a catheterization lab. Imaging will occur only once in the first part of the procedure prior to therapy and typically is in the range of 10 minutes or less depending upon ability to visualize the septum.
Sponsors
NuVera Medical Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
suitable candidates scheduled for elective procedure requiring transseptal access to the left heart eighteen years to eighty years of age signed inform 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. History of chronic GI medical problems involving the esophagus or stomach 4. Active gastrointestinal bleeding, infection or fever (temp> 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 or planning to become pregnant during the study period. 8. History of uncontrolled blood clotting (bleeding or thrombotic) abnormalities 9. Known sensitivities to heparin
Outcome results
None listed