Vision-MR Ablation Catheter 2.0 for Treatment of Ventricular Tachycardia
- Conditions
- Ventricular TachycardiaCardiac arrhythmia10007521
- Registration Number
- NL-OMON53247
- Lead Sponsor
- Imricor Medical Systems, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
• Documented (ECG/EGM) spontaneous episode of sustained ventricular
tachycardia within 6 months
• 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 • Class IV Heart Failure • EF <
25% • Patients with a glomerular filtration rate (GFR) < 30 • Women who are
pregnant • Life expectancy < 12 months • Enrollment in another study without
Imricor approval
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method