VT Ablation in the iCMR

Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia

The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

Inclusion Criteria:

• Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)
• Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure
• Diagnosis of Ischemic Cardiomyopathy
• AAD therapy refractory, contraindicated, not tolerated, or not desired
• 18 years or older

Exclusion Criteria:

• Implanted with non-MR compatible medical devices or contraindicated for an MRI
• Presence of intracardiac thrombus (verified via CT/MRI/TEE/TTE within 48 hours of procedure - or at start of procedure)
• Thrombocytopenia or coagulopathy
• Mechanical mitral and/or aortic valve precluding access to the left ventricle
• Severe aortic stenosis
• Myocardial infarction requiring stent implantation within 90 days of procedure
• Previous cardiac surgery within 60 days of procedures
• Known/uncontrolled stroke risks
• Class IV Heart Failure
• Ejection Fraction (EF) < 25%
• Patients with a glomerular filtration rate (GFR) < 30
• Women who are pregnant
• Allergy to contrast agents (e.g., Gadolinium)
• Active infection
• Known or suspected myxoma
• Unstable angina
• Patients who do not tolerate anticoagulation therapy
• Previous intertribal septal patch or prosthetic atrial septal defect closure device
• Life expectancy < 12 months
• Enrollment in another study without sponsor approval