Overview
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.
Eligibility
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