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โ† Trials
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VT Ablation in the iCMR

RecruitingNAAges 18 Years - anyAllImricor Medical Systems
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Vision-MR Ablation Catheter 2.0
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Where

3 sites
Herzzentrum Leipzig
Leipzig, Germany
Amsterdam UMC
Amsterdam, Netherlands
HagaZiekenhuis
The Hague, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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