VT Ablation in the iCMR

Launched by IMRICOR MEDICAL SYSTEMS · Sep 14, 2022

Keywords

ClinConnect Summary

The VISABL-VT clinical trial is studying a treatment called radiofrequency ablation for patients with ventricular tachycardia, a serious heart condition that can occur with ischemic cardiomyopathy (a type of heart disease caused by reduced blood flow to the heart). This trial is focused on using a special device called the Vision-MR Ablation Catheter 2.0 to see how safe and effective this treatment is for people in a specific MRI environment. The trial is currently looking for participants aged 18 and older who have experienced certain heart rhythm problems and have not responded to other heart medications.

To join the study, participants should have a documented history of heart rhythm issues and a diagnosis of ischemic cardiomyopathy. However, there are some important criteria that may exclude individuals, such as having certain heart devices that are not safe for MRI, recent heart surgeries, or serious health conditions like severe heart failure. If eligible, participants will receive the ablation treatment and will be monitored closely to assess the outcome. This trial aims to provide valuable information on a new approach to managing this challenging heart condition.

Gender

ALL

Eligibility criteria

• 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