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Recruiting NCT05543798

VT Ablation in the iCMR

Trial Parameters

Condition Ventricular Tachycardia
Sponsor Imricor Medical Systems
Study Type INTERVENTIONAL
Phase N/A
Enrollment 64
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-10
Completion 2026-12
Interventions
Vision-MR Ablation Catheter 2.0

Brief Summary

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 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

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