Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Exclusion

• −Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention including heparin and ionic contrast media
• −Renal dysfunction with eGFR \<30 ml/min/1.73mP2
• −Idiopathic VT (VT occurring in subjects without structural heart disease \[including the absence of LGE on MRI, if performed\], metabolic abnormalities or long QT syndrome)
• −Suspected area of ablation of target clinical VT includes aortic root, aortic cusp or any area outside left ventricle except the ventricular septum
• −Subject with a prior ablation within 4 weeks of planned study ablation
• −Subject's VT is not amenable to treatment with the study device at the time of mapping for the study ablation
• −Only PVCs are induced during mapping for the study ablation
• −No clinical VT induced during mapping for the study ablation
• −Planned use of a non-study ablation catheter
• −Subject has an LVEF \< 20% reported on pre-ablation imaging (CT, MRI or echocardiogram within 48 hours of the study procedure)
• −Subject with evidence of any right- or left-sided (including left atrium, left atrial appendage and left ventricle) intracardiac thrombus OR pericardial effusion (except chronic trivial) reported on required pre-ablation imaging (CT, MRI, or echocardiography) or seen on required procedural intracardiac echocardiography (ICE) prior to study ablation catheter insertion.
• −Subjects with atrial fibrillation/flutter (paroxysmal, persistent, or permanent) without uninterrupted anticoagulation for at least 3 weeks immediately prior to the date of ablation procedure. (Interruption of anticoagulation in the day(s) just prior to ablation will be left to physician decision based upon subject's risk of stroke, anticoagulation agent, renal status, and bleed/embolic risk status with recommendation to consider bridging for high-risk subjects.
• −Subjects with NYHA Class IV heart failure
• −Subject with known coagulopathy or other condition likely to increase risk of periprocedural bleeding
• −Subject with known coagulopathy or other condition likely to increase risk of a thrombotic event
• −Subject with a mechanical aortic valve, mechanical mitral valve, or MitraClip
• −Subject with flail mitral leaflet or severe aortic stenosis
• −Subject with LAA occlusion device
• −Subject with a congenital heart defect except patent foramen ovale (PFO)
• −Subject with suspected life expectancy of less than 1 year
• −Subject with myocardial infarction (MI) or unstable angina (UA) within previous 90 days
• −Subject with known untreated significant ischemic coronary artery disease, acute illness (unrelated to VT or its origin) or active systemic infection.
• −Subject with left ventricular assist device planned or required for the procedure
• −Contraindication to cardiac CT
• −Subject concurrently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in any other investigational drug or device study that the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → deems would interfere with study results
• −Subject with a condition (including a chronic illness) or circumstance that the investigator feels puts the subject at an unacceptable risk for participation in the study or may interfere with quality data collection or study results
• −Subject is not willing or is unable to participate in all study procedures and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → requirements
• −Females who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test)
• −Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 90 days